Z-2883-2020Class II

CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled...

Name: Z-2883-2020 CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled...
Creator: GE Healthcare, LLC
Published: 2020-07-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-07-14 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes... on 2020-07-14. FDA classified it as Class II and gives the reason as "The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2883-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-14
Posted: 2020-08-24
Terminated: 2024-09-23
Recalling firm: GE Healthcare
Product: CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On July 14th, 2020 the firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 7/14/2020 to its customers with the following instructions: Safety Instructions You may continue to use the CARESCAPE R860 Ventilator. Ensure that the FiO2 alarm limit is set to the factory default limit +/- 6 % so that the clinician is aware if the measured value differs from set value. When making an extubation decision, use the set FiO2 value instead of the FiO2 measured by the oxygen sensor. The user can use other methods to measure FiO2 or switch to another device and call GE Healthcare. Product Correction: GE Healthcare will correct all affected units at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. Contact Information: If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 2277 units
Distribution: Domestic Distribution: USA International Distribution: Australia, Bahrain, Bermuda, Canada, Egypt, France, Germany, Honduras, India, Iraq, Italy, Lebanon, Mexico, Panama, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Taiwan and United Arab Emirates.
Product codes and lots: CARESCAPE R860: 1506-8600-000 Spare parts: CARESCAPE R860: 1505-3215-000, 2071409-S, 2071410-001 Engstrom: M1115997-S, M1081816-S Identifier # CBRZ03152, CBRZ03159, CBRZ03171, CBRZ03173, CBRZ03174, CBRZ03175, CBRZ03176, CBRZ03177, CBRZ03180, CBRZ03182, CBRZ03867, CBRZ03869, CBRZ03870, CBRZ03873, CBRZ03856, CBRZ03259, CBRZ03261, CBRZ03263, CBRZ03264 CBRZ03265, CBRZ03267, CBRZ03274, CBRZ03275, CBRZ03278, CBRZ03281, CBRZ03928, CBRZ03946, CBRZ03989, CBRZ03990, CBRZ03994, CBRZ03845, CBRZ03857, CBRZ03858, CBRZ03861, CBRZ03868, CBRZ03872, CBRZ03879, CBRZ03880, CBRZ03881, CBRZ03883, CBRZ03889, CBRZ03890, CBRZ03891, CBRZ03484, CBRZ03485, CBRZ03487, CBRZ03488, CBRZ03490, CBRZ03502, CBRZ03793, CBRZ03842, CBRZ03843, CBRZ03849, CBRZ03850, CBRZ03851, CBRZ03853, CBRZ03864, CBRZ03865, CBRZ03866, CBRZ03438, CBRZ03501, CBRZ03503, CBRZ03506, CBRZ03508, CBRZ03609, CBRZ03610, CBRZ03620, CBRZ03621, CBRZ03625, CBRZ03342, CBRZ03437, CBRZ03451, CBRZ03724, CBRZ03730, CBRZ03731, CBRZ03732, CBRZ03733, CBRZ03734, CBRZ03759, CBRZ03767, CBRZ03768, CBRZ03769, CBRZ03771, CBRZ03772, CBRZ03773, CBRZ03774, CBRZ03775, CBRZ03776, CBRZ03777, CBRZ03778, CBRZ03779, CBRZ03780, CBRZ03781, CBRZ03782, CBRZ03783, CBRZ03784, CBRZ03785, CBRZ03786, CBRZ03787, CBRZ03788, CBRZ03789, CBRZ03791, CBRZ03792, CBRZ03794, CBRZ03795, CBRZ03796, CBRZ03797, CBRZ03798, CBRZ03799, CBRZ03800, CBRZ03801, CBRZ03802, CBRZ03803, CBRZ03804, CBRZ03805, CBRZ03806, CBRZ03807, CBRZ03808, CBRZ03809, CBRZ03810, CBRZ03812, CBRZ03813, CBRZ03815, CBRZ03816, CBRZ03817, CBRZ03819, CBRZ03821, CBRZ03822, CBRZ03823, CBRZ03824, CBRZ03825, CBRZ03826, CBRZ03827, CBRZ03828, CBRZ03829, CBRZ03830, CBRZ03831, CBRZ03832, CBRZ03834, CBRZ03835, CBRZ03836, CBRZ03837, CBRZ03838, CBRZ03839, CBRZ03841, CBRZ03877, CBRZ03913, CBRZ03925, CBRZ03949, CBRZ03951, CBRZ03952, CBRZ03954, CBRZ03955, CBRZ03956, CBRZ03957, CBRZ03958, CBRZ03959, CBRZ03961, CBRZ03962, CBRZ03979, CBRZ03984, CBRZ03985, CBRZ03997, CBRZ03998, CBRZ04001, CBRZ04003, CBRZ04006, CBRZ04008, CBRZ04009, CBRZ04011, CBRZ04020, CBRZ04025, CBRZ04036, CBRZ04038, CBRZ04039, CBRZ04040, CBRZ04041, CBRZ04042, CBRZ04043, CBRZ04046, CBRZ04047, CBRZ04050, CBRZ04051, CBRZ04052, CBRZ04053, CBRZ04054, CBRZ04057, CBRZ04058, CBRZ04059, CBRZ04061, CBRZ04062, CBRZ04063, CBRZ04064, CBRZ04065, CBRZ04066, CBRZ04067, CBRZ04068, CBRZ04069, CBRZ04070, CBRZ04071, CBRZ04072, CBRZ04073, CBRZ04074, CBRZ04075, CBRZ04076, CBRZ04078, CBRZ04080, CBRZ04081, CBRZ04082, CBRZ04083, CBRZ04084, CBRZ04085, CBRZ04086, CBRZ04087, CBRZ04088, CBRZ04089, CBRZ04090, CBRZ04091, CBRZ04092, CBRZ04093, CBRZ04094, CBRZ04095, CBRZ04096, CBRZ04097, CBRZ04098, CBRZ04099, CBRZ04100, CBRZ04101, CBRZ04102, CBRZ04103, CBRZ04104, CBRZ04105, CBRZ04106, CBRZ04107, CBRZ04108, CBRZ04109, CBRZ04110, CBRZ04111, CBRZ04112, CBRZ04113, CBRZ04115, CBRZ04116, CBRZ04117, CBRZ04118, CBRZ04119, CBRZ04120, CBRZ04121, CBRZ04122, CBRZ04123, CBRZ04124, CBRZ04130, CBRZ04137, CBRZ04139, CBRZ04196, CBRZ04212, CBRZ04269, CBRZ04273, CBRZ04330, CBRZ04336, CBRZ04373, CBRZ04374, CBRZ04376, CBRZ04377, CBRZ04378, CBRZ04379, CBRZ04380, CBRZ04387, CBRZ04389, CBRZ04438, CBRZ04446, CBRZ04447, CBRZ04449, CBRZ04450, CBRZ04485, CBRZ04491, CBRZ04506, CBRZ04511, CBRZ04524, CBRZ04649, CBRZ04684, CBRZ04692, CBRZ04693, CBRZ04694, CBRZ04695, CBRZ04696, CBRZ04698, CBRZ04699, CBRZ04700, CBRZ04701, CBRZ04702, CBRZ04703, CBRZ04704, CBRZ04705, CBRZ04706, CBRZ04707, CBRZ04708, CBRZ04709, CBRZ04710, CBRZ04711, CBRZ04712, CBRZ04713, CBRZ04714, CBRZ04715, CBRZ04716, CBRZ04717, CBRZ04718, CBRZ04719, CBRZ04720, CBRZ04721, CBRZ04722, CBRZ04723, CBRZ04724, CBRZ04725, CBRZ04726, CBRZ04727, CBRZ04728, CBRZ04729, CBRZ04730, CBRZ04731, CBRZ04733, CBRZ04734, CBRZ04735, CBRZ04736, CBRZ04737, CBRZ04738, CBRZ04739, CBRZ04740, CBRZ04741, CBRZ04742, CBRZ04743, CBRZ04744, CBRZ04745, CBRZ04746, CBRZ04747, CBRZ04748, CBRZ04749, CBRZ04750, CBRZ04751, CBRZ04752, CBRZ04753, CBRZ04754, CBRZ04755, CBRZ04759, CBRZ04762, CBRZ04770, CBRZ04772, CBRZ04778, CBRZ04779, CBRZ04788, CBRZ04790, CBRZ04791, CBRZ04800, CBRZ04813, CBRZ04814, CBRZ04815, CBRZ04816, CBRZ04817, CBRZ04818, CBRZ04819, CBRZ04820, CBRZ04821, CBRZ04822, CBRZ04823, CBRZ04824, CBRZ04825, CBRZ04826, CBRZ04827, CBRZ04828, CBRZ04829, CBRZ04830, CBRZ04831, CBRZ04832, CBRZ04833, CBRZ04834, CBRZ04837,CBRZ04838, CBRZ04839, CBRZ04840, CBRZ04841, CBRZ04842, CBRZ04843, CBRZ04847, CBRZ04848, CBRZ04849, CBRZ04850, CBRZ04851, CBRZ04852, CBRZ04853, CBRZ04854, CBRZ04855, CBRZ04856, CBRZ04857, CBRZ04859, CBRZ04860, CBRZ04861, CBRZ04862, CBRZ04863, CBRZ04864, CBRZ04865, CBRZ04866, CBRZ04867, CBRZ04868, CBRZ04869, CBRZ04870, CBRZ04871, CBRZ04872, CBRZ04873, CBRZ04874, CBRZ04875, CBRZ04876, CBRZ04877, CBRZ04878, CBRZ04879, CBRZ04880, CBRZ04881, CBRZ04882, CBRZ04883, CBRZ04884, CBRZ04885, CBRZ04886, CBRZ04887, CBRZ04888, CBRZ04889, CBRZ04890, CBRZ04891, CBRZ04892, CBRZ04893, CBRZ04894, CBRZ04895, CBRZ04897, CBRZ04898, CBRZ04899, CBRZ04900, CBRZ04901, CBRZ04902, CBRZ04903, CBRZ04904, CBRZ04905, CBRZ04906, CBRZ04907, CBRZ04908, CBRZ04909, CBRZ04910, CBRZ04911, CBRZ04912, CBRZ04913, CBRZ04914, CBRZ04915, CBRZ04917, CBRZ04918, CBRZ04919, CBRZ04920, CBRZ04921, CBRZ04922, CBRZ04923, CBRZ04924, CBRZ04925, CBRZ04927, CBRZ04928, CBRZ04929, CBRZ04930, CBRZ04931, CBRZ04932, CBRZ04933, CBRZ04934, CBRZ04935, CBRZ04936, CBRZ04947, CBRZ04951, CBRZ05012, CBRZ05013, CBRZ05014, CBRZ05015, CBRZ05016, CBRZ05017, CBRZ05018, CBRZ05019, CBRZ05020, CBRZ05021, CBRZ05022, CBRZ05023, CBRZ05024, CBRZ05025, CBRZ05026, CBRZ05027, CBRZ05028, CBRZ05029, CBRZ05030, CBRZ05031, CBRZ05032, CBRZ05033, CBRZ05034, CBRZ05035, CBRZ05036, CBRZ05037, CBRZ05038, CBRZ05039, CBRZ05040, CBRZ05041, CBRZ05042, CBRZ05043, CBRZ05044, CBRZ05045, CBRZ05046, CBRZ05047, CBRZ05048, CBRZ05049, CBRZ05050, CBRZ05051,CBRZ05052, CBRZ05053, CBRZ05054, CBRZ05055, CBRZ05056, CBRZ05057, CBRZ05058, CBRZ05059, CBRZ05060, CBRZ05061, CBRZ05062, CBRZ05063, CBRZ05064, CBRZ05065, CBRZ05066, CBRZ05067, CBRZ05068, CBRZ05069, CBRZ05070, CBRZ05071, CBRZ05072, CBRZ05073, CBRZ05074, CBRZ05075, CBRZ05076, CBRZ05077, CBRZ05078, CBRZ05079, CBRZ05080, CBRZ05081, CBRZ05082, CBRZ05083, CBRZ05084, CBRZ05085, CBRZ05086, CBRZ05087, CBRZ05088, CBRZ05089, CBRZ05090, CBRZ05091, CBRZ05092, CBRZ05093, CBRZ05094, CBRZ05095, CBRZ05096, CBRZ05097, CBRZ05098, CBRZ05099, CBRZ05100, CBRZ05101, CBRZ05102, CBRZ05103, CBRZ05106, CBRZ05107, CBRZ05108, CBRZ05109, CBRZ05110, CBRZ05111, CBRZ05112, CBRZ05113 CBRZ05114, CBRZ05115, CBRZ05116, CBRZ05117, CBRZ05118, CBRZ05119, CBRZ05120, CBRZ05121, CBRZ05122, CBRZ05123, CBRZ05124, CBRZ05125, CBRZ05126, CBRZ05127, CBRZ05128, CBRZ05129, CBRZ05130, CBRZ05131, CBRZ05132, CBRZ05133, CBRZ05134, CBRZ05135, CBRZ05136, CBRZ05137, CBRZ05138, CBRZ05139, CBRZ05140, CBRZ05141, CBRZ05142, CBRZ05143, CBRZ05144, CBRZ05145, CBRZ05146, CBRZ05147, CBRZ05148, CBRZ05149, CBRZ05150, CBRZ05151, CBRZ05152, CBRZ05154, CBRZ05153, CBRZ05155, CBRZ05156, CBRZ05157, CBRZ05158, CBRZ05159, CBRZ05160, CBRZ05161, CBRZ05162, CBRZ05163, CBRZ05164, CBRZ05165, CBRZ05166, CBRZ05167, CBRZ05168, CBRZ05169, CBRZ05170, CBRZ05171, CBRZ05172, CBRZ05173, CBRZ05174, CBRZ05175, CBRZ05176, CBRZ05177, CBRZ05178 CBRZ05179, CBRZ05180, CBRZ05181, CBRZ05182, CBRZ05183, CBRZ05184, CBRZ05185, CBRZ05186, CBRZ05187, CBRZ05188, CBRZ05189, CBRZ05190, CBRZ05191, CBRZ05192, CBRZ05193, CBRZ05194, CBRZ05195, CBRZ05196, CBRZ05197, CBRZ05198, CBRZ05199, CBRZ05200, CBRZ05201, CBRZ05202, CBRZ05203, CBRZ05204, CBRZ05205, CBRZ05206, CBRZ05207, CBRZ05208, CBRZ05209, CBRZ05210, CBRZ05211, CBRZ05212, CBRZ05213, CBRZ05214, CBRZ05215, CBRZ05216, CBRZ05217, CBRZ05218, CBRZ05219, CBRZ05220, CBRZ05221, CBRZ05222, CBRZ05223, CBRZ05224, CBRZ05225, CBRZ05226, CBRZ05227, CBRZ05228, CBRZ05229, CBRZ05230, CBRZ05231, CBRZ05232, CBRZ05233, CBRZ05234, CBRZ05235, CBRZ05236, CBRZ05237, CBRZ05238, CBRZ05239, CBRZ05241, CBRZ05242, CBRZ05244, CBRZ05245, CBRZ05247, CBRZ05248, CBRZ05249, CBRZ05252, CBRZ05255, CBRZ05256, CBRZ05257, CBRZ05258, CBRZ05259, CBRZ05260, CBRZ05261, CBRZ05262, CBRZ05263, CBRZ05264, CBRZ05265, CBRZ05266, CBRZ05267, CBRZ05268, CBRZ05273, CBRZ05276, CBRZ05277, CBRZ05278, CBRZ05279, CBRZ05280, CBRZ05281, CBRZ05282, CBRZ05283, CBRZ05284, CBRZ05285, CBRZ05286, CBRZ05287, CBRZ05288, CBRZ05289, CBRZ05290, CBRZ05291, CBRZ05292, CBRZ05294, CBRZ05295, CBRZ05296, CBRZ05302, CBRZ05303, CBRZ05304, CBRZ05305, CBRZ05306, CBRZ05309, CBRZ05311, CBRZ05312, CBRZ05313, CBRZ05314 CBRZ05315, CBRZ05317, CBRZ05318, CBRZ05319, CBRZ05320, CBRZ05321, CBRZ05322, CBRZ05323, CBRZ05324, CBRZ05326, CBRZ05327, CBRZ05328, CBRZ05329, CBRZ05330 CBRZ05331, CBRZ05332, CBRZ05333, CBRZ05334, CBRZ05335, CBRZ05340, CBRZ40010, CBRZ40038, CBRZ40039, CBRZ40040, CBRZ03469, CBRZ03504, CBRZ03505, CBRZ03510, CBRZ03513, CBRZ03514, CBRZ03515, CBRZ03516, CBRZ03517, CBRZ03518, CBRZ03522, CBRZ03523, CBRZ03526, CBRZ03531, CBRZ03532, CBRZ03533, CBRZ03534, CBRZ03535, CBRZ03536, CBRZ03537, CBRZ03538, CBRZ03539, CBRZ03540, CBRZ03541, CBRZ03543, CBRZ03544, CBRZ03548, CBRZ03550, CBRZ03552, CBRZ02183, CBRZ03110, CBRZ03128, CBRZ03130, CBRZ03131, CBRZ03132, CBRZ03133, CBRZ03134, CBRZ03135, CBRZ03136, CBRZ03137, CBRZ03138, CBRZ03139, CBRZ03140, CBRZ03141, CBRZ03142, CBRZ03143, CBRZ03144, CBRZ03145, CBRZ03146, CBRZ03147, CBRZ03148, CBRZ03149, CBRZ03150, CBRZ03151, CBRZ03153, CBRZ03154, CBRZ03156, CBRZ03158, CBRZ03160, CBRZ03161, CBRZ03163, CBRZ03164, CBRZ03165, CBRZ03167, CBRZ03170, CBRZ03185, CBRZ03188, CBRZ03202, CBRZ03206, CBRZ03208, CBRZ03209, CBRZ03210, CBRZ03211, CBRZ03212, CBRZ03213, CBRZ03214, CBRZ03215, CBRZ03216, CBRZ03217, CBRZ03218, CBRZ03219, CBRZ03220, CBRZ03221, CBRZ03222, CBRZ03223, CBRZ03226, CBRZ03227, CBRZ03228, CBRZ03229, CBRZ03230, CBRZ03232, CBRZ03234, CBRZ03236, CBRZ03237, CBRZ03238, CBRZ03239, CBRZ03240, CBRZ03241, CBRZ03242, CBRZ03243, CBRZ03244, CBRZ03245, CBRZ03246, CBRZ03247, CBRZ03248, CBRZ03249, CBRZ03250, CBRZ03251, CBRZ03252, CBRZ03253, CBRZ03254, CBRZ03255, CBRZ03256, CBRZ03258, CBRZ03262, CBRZ03269, CBRZ03270, CBRZ03271, CBRZ03272, CBRZ03273, CBRZ03277, CBRZ03279, CBRZ03280, CBRZ03283, CBRZ03286, CBRZ03287, CBRZ03288, CBRZ03289, CBRZ03290, CBRZ03291, CBRZ03292, CBRZ03293, CBRZ03294, CBRZ03295, CBRZ03296, CBRZ03297, CBRZ03298, CBRZ03299, CBRZ03300,CBRZ03301, CBRZ03302, CBRZ03303, CBRZ03304, CBRZ03305, CBRZ03306, CBRZ03307, CBRZ03308, CBRZ03309, CBRZ03310, CBRZ03311, CBRZ03315, CBRZ03317, CBRZ03318, CBRZ03319, CBRZ03320, CBRZ03321, CBRZ03322, CBRZ03323, CBRZ03324, CBRZ03325, CBRZ03326 ,CBRZ03327, CBRZ03329, CBRZ03330, CBRZ03331, CBRZ03332, CBRZ03333, CBRZ03334, CBRZ03335, CBRZ03336, CBRZ03337, CBRZ03338, CBRZ03339, CBRZ03340, CBRZ03341, CBRZ03343, CBRZ03344, CBRZ03345, CBRZ03346, CBRZ03347, CBRZ03348, CBRZ03349, CBRZ03350, CBRZ03351, CBRZ03352, CBRZ03353, CBRZ03354, CBRZ03355, CBRZ03356, CBRZ03357, CBRZ03358, CBRZ03359, CBRZ03360, CBRZ03361, CBRZ03362, CBRZ03363, CBRZ03364, CBRZ03365, CBRZ03366, CBRZ03367, CBRZ03368, CBRZ03369, CBRZ03370, CBRZ03371, CBRZ03372, CBRZ03373, CBRZ03374, CBRZ03375, CBRZ03376, CBRZ03377, CBRZ03378, CBRZ03379, CBRZ03380, CBRZ03381, CBRZ03382, CBRZ03383, CBRZ03384, CBRZ03385, CBRZ03386, CBRZ03387, CBRZ03388, CBRZ03389, CBRZ03390, CBRZ03391, CBRZ03392, CBRZ03393, CBRZ03394, CBRZ03395, CBRZ03396, CBRZ03397, CBRZ03398, CBRZ03399, CBRZ03400, CBRZ03401, CBRZ03402, CBRZ03403, CBRZ03404, CBRZ03405, CBRZ03406, CBRZ03407, CBRZ03408, CBRZ03409, CBRZ03410, CBRZ03411, CBRZ03412, CBRZ03413, CBRZ03414, CBRZ03415, CBRZ03416, CBRZ03417, CBRZ03418, CBRZ03419, CBRZ03420, CBRZ03421, CBRZ03422, CBRZ03423, CBRZ03424, CBRZ03425, CBRZ03426, CBRZ03428, CBRZ03429, CBRZ03430, CBRZ03431, CBRZ03432, CBRZ03433, CBRZ03434, CBRZ03435, CBRZ03436, CBRZ03439, CBRZ03440, CBRZ03441, CBRZ03442, CBRZ03443, CBRZ03444, CBRZ03445, CBRZ03446, CBRZ03447, CBRZ03448, CBRZ03449, CBRZ03450, CBRZ03452, CBRZ03453, CBRZ03454, CBRZ03455, CBRZ03456, CBRZ03457, CBRZ03458, CBRZ03459, CBRZ03460, CBRZ03461, CBRZ03462, CBRZ03463, CBRZ03464, CBRZ03465, CBRZ03466, CBRZ03467, CBRZ03468 CBRZ03470, CBRZ03471, CBRZ03473, CBRZ03474, CBRZ03475, CBRZ03476, CBRZ03479, CBRZ03480, CBRZ03481, CBRZ03486, CBRZ03507, CBRZ03512, CBRZ03519, CBRZ03520, CBRZ03524, CBRZ03525, CBRZ03527, CBRZ03529, CBRZ03530, CBRZ03542, CBRZ03545, CBRZ03546, CBRZ03547, CBRZ03549, CBRZ03551, CBRZ03553, CBRZ03554, CBRZ03555, CBRZ03556, CBRZ03557, CBRZ03558, CBRZ03559, CBRZ03560, CBRZ03561, CBRZ03562, CBRZ03563, CBRZ03564, CBRZ03565, CBRZ03566, CBRZ03567, CBRZ03568, CBRZ03569, CBRZ03570, CBRZ03571, CBRZ03572, CBRZ03573, CBRZ03574, CBRZ03576, CBRZ03577, CBRZ03578, CBRZ03579, CBRZ03580, CBRZ03581, CBRZ03582, CBRZ03583, CBRZ03584, CBRZ03585, CBRZ03586, CBRZ03587, CBRZ03588, CBRZ03589, CBRZ03590, CBRZ03591, CBRZ03592, CBRZ03594, CBRZ03595, CBRZ03599, CBRZ03601, CBRZ03604, CBRZ03605, CBRZ03606, CBRZ03607, CBRZ03608, CBRZ03611, CBRZ03612, CBRZ03613, CBRZ03614, CBRZ03615, CBRZ03617, CBRZ03618, CBRZ03619, CBRZ03626, CBRZ03628, CBRZ03631, CBRZ03633, CBRZ03634, CBRZ03635, CBRZ03636, CBRZ03637, CBRZ03638, CBRZ03639, CBRZ03640, CBRZ03641, CBRZ03643, CBRZ03644, CBRZ03645, CBRZ03648, CBRZ03650, CBRZ03651, CBRZ03652, CBRZ03653, CBRZ03654, CBRZ03655, CBRZ03656, CBRZ03657, CBRZ03658, CBRZ03659, CBRZ03660, CBRZ03661, CBRZ03662, CBRZ03663, CBRZ03664, CBRZ03665, CBRZ03667, CBRZ03668, CBRZ03670, CBRZ03689, CBRZ03695, CBRZ03707, CBRZ03712, CBRZ03714, CBRZ03716, CBRZ03717, CBRZ03718, CBRZ03719, CBRZ03720, CBRZ03721, CBRZ03722, CBRZ03723, CBRZ03725, CBRZ03726, CBRZ03727, CBRZ03728, CBRZ03729, CBRZ03736, CBRZ03738, CBRZ03739, CBRZ03740, CBRZ03741, CBRZ03745, CBRZ03747, CBRZ03748, CBRZ03749, CBRZ03750, CBRZ03751, CBRZ03752, CBRZ03753, CBRZ03754, CBRZ03755, CBRZ03756, CBRZ03757, CBRZ03758, CBRZ03760, CBRZ03761, CBRZ03762, CBRZ03763, CBRZ03764, CBRZ03765, CBRZ03766, CBRZ03770, CBRZ03903, CBRZ03932, CBRZ03943, CBRZ03944, CBRZ03945, CBRZ03953, CBRZ03960, CBRZ03963, CBRZ03964, CBRZ03965, CBRZ03966, CBRZ03967, CBRZ03968, CBRZ03969, CBRZ03970, CBRZ03971, CBRZ03972, CBRZ03973, CBRZ03974, CBRZ03975, CBRZ03976, CBRZ03977, CBRZ03978, CBRZ03981, CBRZ03982, CBRZ03983, CBRZ03991, CBRZ03992, CBRZ03993, CBRZ03995, CBRZ03996, CBRZ03999, CBRZ04000, CBRZ04002, CBRZ04004, CBRZ04005, CBRZ04007, CBRZ04010, CBRZ04012, CBRZ04013, CBRZ04016, CBRZ04017, CBRZ04018, CBRZ04019, CBRZ04027, CBRZ04029, CBRZ04030, CBRZ04032, CBRZ04033, CBRZ04034, CBRZ04035, CBRZ04037, CBRZ04044, CBRZ04045, CBRZ04048, CBRZ04049, CBRZ04055, CBRZ04056, CBRZ04060, CBRZ04077, CBRZ04079, CBRZ04114, CBRZ04126, CBRZ04127, CBRZ04128, CBRZ04129, CBRZ04131, CBRZ04132, CBRZ04133, CBRZ04134, CBRZ04135, CBRZ04136, CBRZ04138, CBRZ04140, CBRZ04141, CBRZ04142, CBRZ04143, CBRZ04144, CBRZ04145, CBRZ04146, CBRZ04147, CBRZ04148, CBRZ04149, CBRZ04150, CBRZ04151,CBRZ04152, CBRZ04153, CBRZ04154, CBRZ04155, CBRZ04156, CBRZ04157, CBRZ04158, CBRZ04159, CBRZ04160, CBRZ04161, CBRZ04162, CBRZ04163, CBRZ04164, CBRZ04165, CBRZ04166, CBRZ04167, CBRZ04168, CBRZ04169, CBRZ04170, CBRZ04171, CBRZ04173, CBRZ04174, CBRZ04175, CBRZ04177, CBRZ04178, CBRZ04179, CBRZ04180, CBRZ04181, CBRZ04182, CBRZ04183, CBRZ04184, CBRZ04185, CBRZ04186, CBRZ04187, CBRZ04188, CBRZ04189, CBRZ04190, CBRZ04191, CBRZ04192, CBRZ04193, CBRZ04194, CBRZ04195, CBRZ04197, CBRZ04198, CBRZ04199, CBRZ04200, CBRZ04201, CBRZ04202, CBRZ04203, CBRZ04204, CBRZ04205, CBRZ04206, CBRZ04207, CBRZ04208, CBRZ04209, CBRZ04210, CBRZ04211, CBRZ04213, CBRZ04214, CBRZ04215, CBRZ04216, CBRZ04217, CBRZ04218, CBRZ04219, CBRZ04220, CBRZ04221, CBRZ04222, CBRZ04223, CBRZ04224, CBRZ04225, CBRZ04226, CBRZ04227, CBRZ04228, CBRZ04229, CBRZ04230, CBRZ04231, CBRZ04232, CBRZ04233, CBRZ04234, CBRZ04235, CBRZ04236, CBRZ04237, CBRZ04238, CBRZ04239, CBRZ04240, CBRZ04241, CBRZ04242, CBRZ04243, CBRZ04244, CBRZ04245, CBRZ04246, CBRZ04247, CBRZ04248, CBRZ04249, CBRZ04250, CBRZ04251, CBRZ04252, CBRZ04253, CBRZ04254, CBRZ04255, CBRZ04256, CBRZ04257, CBRZ04258, CBRZ04259, CBRZ04260, CBRZ04261, CBRZ04262, CBRZ04263, CBRZ04264, CBRZ04265, CBRZ04266, CBRZ04267, CBRZ04268, CBRZ04270, CBRZ04271, CBRZ04272, CBRZ04274, CBRZ04275, CBRZ04276, CBRZ04277, CBRZ04278, CBRZ04279, CBRZ04280, CBRZ04281, CBRZ04282, CBRZ04283, CBRZ04284, CBRZ04285, CBRZ04286, CBRZ04287, CBRZ04288, CBRZ04289, CBRZ04290, CBRZ04291, CBRZ04292, CBRZ04293, CBRZ04294, CBRZ04295, CBRZ04296, CBRZ04297, CBRZ04298, CBRZ04299, CBRZ04300, CBRZ04301, CBRZ04302, CBRZ04303, CBRZ04304, CBRZ04305, CBRZ04306, CBRZ04307, CBRZ04308, CBRZ04309, CBRZ04310, CBRZ04311, CBRZ04312, CBRZ04313, CBRZ04314, CBRZ04315, CBRZ04316, CBRZ04317, CBRZ04318, CBRZ04319, CBRZ04320, CBRZ04321, CBRZ04322, CBRZ04323, CBRZ04324, CBRZ04325, CBRZ04326, CBRZ04327, CBRZ04328, CBRZ04329, CBRZ04331, CBRZ04332, CBRZ04333, CBRZ04334, CBRZ04335, CBRZ04337, CBRZ04338, CBRZ04339, CBRZ04340, CBRZ04341, CBRZ04343, CBRZ04344, CBRZ04345, CBRZ04346, CBRZ04347, CBRZ04348, CBRZ04349, CBRZ04350, CBRZ04351, CBRZ04352, CBRZ04353, CBRZ04354, CBRZ04355, CBRZ04356, CBRZ04357, CBRZ04358, CBRZ04359, CBRZ04365, CBRZ04366, CBRZ04367, CBRZ04368, CBRZ04369, CBRZ04370, CBRZ04371, CBRZ04372, CBRZ04375, CBRZ04381, CBRZ04382, CBRZ04383, CBRZ04384, CBRZ04385, CBRZ04386, CBRZ04388, CBRZ04390, CBRZ04391, CBRZ04392, CBRZ04393, CBRZ04394, CBRZ04395, CBRZ04396, CBRZ04397, CBRZ04398, CBRZ04399, CBRZ04400, CBRZ04401, CBRZ04402, CBRZ04403, CBRZ04404, CBRZ04405, CBRZ04406, CBRZ04407, CBRZ04408, CBRZ04409, CBRZ04410, CBRZ04411, CBRZ04412, CBRZ04413, CBRZ04414, CBRZ04415, CBRZ04416, CBRZ04417, CBRZ04418, CBRZ04419, CBRZ04420, CBRZ04421, CBRZ04422, CBRZ04423, CBRZ04424, CBRZ04425, CBRZ04426, CBRZ04427, CBRZ04428, CBRZ04429, CBRZ04430, CBRZ04431, CBRZ04432, CBRZ04433, CBRZ04434, CBRZ04435, CBRZ04436, CBRZ04437, CBRZ04439, CBRZ04440, CBRZ04441, CBRZ04442, CBRZ04443, CBRZ04444, CBRZ04445, CBRZ04448, CBRZ04451, CBRZ04452, CBRZ04453, CBRZ04454, CBRZ04455, CBRZ04456, CBRZ04457, CBRZ04458, CBRZ04459, CBRZ04460, CBRZ04461, CBRZ04462, CBRZ04463, CBRZ04464, CBRZ04465, CBRZ04466, CBRZ04467, CBRZ04468, CBRZ04469, CBRZ04470, CBRZ04471, CBRZ04472, CBRZ04473, CBRZ04474, CBRZ04475, CBRZ04476, CBRZ04477, CBRZ04478, CBRZ04479, CBRZ04480, CBRZ04481, CBRZ04482, CBRZ04483, CBRZ04484, CBRZ04486, CBRZ04487, CBRZ04488, CBRZ04489, CBRZ04490, CBRZ04492, CBRZ04493, CBRZ04494, CBRZ04495, CBRZ04496, CBRZ04497, CBRZ04498, CBRZ04499, CBRZ04500, CBRZ04501, CBRZ04502, CBRZ04503, CBRZ04504, CBRZ04505, CBRZ04507, CBRZ04508, CBRZ04509, CBRZ04510, CBRZ04512, CBRZ04513, CBRZ04514, CBRZ04515, CBRZ04516, CBRZ04517, CBRZ04518, CBRZ04519, CBRZ04520, CBRZ04521, CBRZ04522, CBRZ04523, CBRZ04525, CBRZ04526, CBRZ04527, CBRZ04528, CBRZ04529, CBRZ04530, CBRZ04531, CBRZ04532, CBRZ04533, CBRZ04534, CBRZ04535, CBRZ04536, CBRZ04537, CBRZ04538, CBRZ04539, CBRZ04540, CBRZ04541, CBRZ04542, CBRZ04543, CBRZ04544, CBRZ04545, CBRZ04546, CBRZ04547, CBRZ04548, CBRZ04549, CBRZ04550, CBRZ04551, CBRZ04552, CBRZ04553, CBRZ04554, CBRZ04555, CBRZ04556, CBRZ04557, CBRZ04558, CBRZ04559, CBRZ04560, CBRZ04561, CBRZ04562, CBRZ04563, CBRZ04564, CBRZ04565, CBRZ04566, CBRZ04567, CBRZ04568, CBRZ04569, CBRZ04570, CBRZ04571, CBRZ04572, CBRZ04573, CBRZ04574, CBRZ04575, CBRZ04576, CBRZ04577, CBRZ04578, CBRZ04579, CBRZ04580, CBRZ04581, CBRZ04582, CBRZ04583, CBRZ04584, CBRZ04585, CBRZ04586, CBRZ04587, CBRZ04588, CBRZ04589, CBRZ04590, CBRZ04591, CBRZ04592, CBRZ04593, CBRZ04594, CBRZ04595, CBRZ04596, CBRZ04597, CBRZ04598, CBRZ04599, CBRZ04600, CBRZ04601, CBRZ04602, CBRZ04603, CBRZ04604, CBRZ04605, CBRZ04606, CBRZ04607, CBRZ04608, CBRZ04609, CBRZ04610, CBRZ04611, CBRZ04612, CBRZ04613, CBRZ04614, CBRZ04615, CBRZ04616, CBRZ04617, CBRZ04618, CBRZ04619, CBRZ04620, CBRZ04621, CBRZ04622, CBRZ04623, CBRZ04624, CBRZ04625, CBRZ04626, CBRZ04627, CBRZ04628, CBRZ04629, CBRZ04630, CBRZ04631, CBRZ04632, CBRZ04633, CBRZ04634, CBRZ04635, CBRZ04636, CBRZ04637, CBRZ04638, CBRZ04639, CBRZ04640, CBRZ04641, CBRZ04642, CBRZ04643, CBRZ04644, CBRZ04645, CBRZ04646, CBRZ04647, CBRZ04648, CBRZ04650, CBRZ04651, CBRZ04652, CBRZ04653, CBRZ04654, CBRZ04655, CBRZ04656, CBRZ04657, CBRZ04658, CBRZ04659, CBRZ04660, CBRZ04661, CBRZ04662, CBRZ04663, CBRZ04664, CBRZ04665, CBRZ04666, CBRZ04667, CBRZ04668, CBRZ04669, CBRZ04670, CBRZ04671, CBRZ04672, CBRZ04673, CBRZ04674, CBRZ04675, CBRZ04676, CBRZ04677, CBRZ04678, CBRZ04679, CBRZ04680, CBRZ04681, CBRZ04682, CBRZ04683, CBRZ04685, CBRZ04686, CBRZ04687, CBRZ04688, CBRZ04689, CBRZ04690, CBRZ04691, CBRZ04697, CBRZ04732, CBRZ04756, CBRZ04757, CBRZ04758, CBRZ04760, CBRZ04761, CBRZ04763, CBRZ04764, CBRZ04765, CBRZ04766, CBRZ04767, CBRZ04768, CBRZ04769, CBRZ04771, CBRZ04773, CBRZ04774, CBRZ04775, CBRZ04776, CBRZ04777, CBRZ04780, CBRZ04781, CBRZ04782, CBRZ04783, CBRZ04784, CBRZ04785, CBRZ04786, CBRZ04787, CBRZ04789, CBRZ04792, CBRZ04793, CBRZ04794, CBRZ04795, CBRZ04796, CBRZ04797, CBRZ04798, CBRZ04799, CBRZ04801, CBRZ04802, CBRZ04803, CBRZ04804, CBRZ04805, CBRZ04806, CBRZ04807, CBRZ04808, CBRZ04809, CBRZ04810, CBRZ04811, CBRZ04812, CBRZ04835, CBRZ04836, CBRZ04844, CBRZ04845, CBRZ04846, CBRZ04858, CBRZ04896, CBRZ04916, CBRZ04926, CBRZ04937, CBRZ04938, CBRZ04939, CBRZ04940, CBRZ04941, CBRZ04942, CBRZ04943, CBRZ04944, CBRZ04945, CBRZ04946, CBRZ04948, CBRZ04949, CBRZ04950, CBRZ04952, CBRZ04953, CBRZ05010, CBRZ05011,CBRZ05243, CBRZ05246, CBRZ05250, CBRZ05251, CBRZ05253, CBRZ05254, CBRZ05269, CBRZ05270, CBRZ05271, CBRZ05272, CBRZ05274, CBRZ05275, CBRZ05297, CBRZ05298, CBRZ05299, CBRZ05300, CBRZ05301, CBRZ05308, CBRZ05316, CBRZ05339, CBRZ40011, CBRZ40012, CBRZ40013, CBRZ40014, CBRZ40015, CBRZ40016, CBRZ40017, CBRZ40018, CBRZ40019, CBRZ40020, CBRZ40021, CBRZ40022, CBRZ40023, CBRZ40024, CBRZ40025, CBRZ40026, CBRZ40027, CBRZ40028, CBRZ40029, CBRZ40030, CBRZ40031, CBRZ40032, CBRZ40033, CBRZ40034, CBRZ40035, CBRZ40036, CBRZ40037, CBRZ03627, CBRZ03632, CBRZ03642, CBRZ03491, CBRZ03818, CBRZ03840, CBRZ03844, CBRZ03846, CBRZ03847, CBRZ03478, CBRZ03509, CBRZ03511, CBRZ03521, CBRZ03528, CBRZ03172, CBRZ03183, CBRZ03189, CBRZ03190, CBRZ03192, CBRZ03477, CBRZ03500, CBRZ03472, CBRZ03489, CBRZ03493, CBRZ03312, CBRZ03313, CBRZ03314, CBRZ03316, CBRZ03328, 70187546-2, 70187546-3, 70187742-5, 70187742-6, 70187742-7, 70187742-8, 70187742-9, 70189854-4, 70189854-5, CBRZ03181, CBRZ03184, CBRZ03186, CBRZ03191, CBRZ03194, CBRZ03933, CBRZ03986, CBRZ03988, CBRZ03947, CBRZ03950, CBRZ03980, CBRZ03987, CBRZ03622, CBRZ03623, CBRZ03624, CBRZ03629, CBRZ03630, CBRZ03427, CBRZ03482, CBRZ03483, CBRZ03492, CBRZ03494, CBRZ03742, CBRZ03705, CBRZ03708, CBRZ03710, CBRZ03715, CBRZ03073, CBRZ03074, CBRZ03076, CBRZ03080, CBRZ03082.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2883-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2883-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-24

Product code CBK

K142679Class IICarescape R860Datex-Ohmeda, Inc. / cleared 2015-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)