510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-2429-2020Class II

Oscar 2, Model 250 System

Suntech Medical, Inc. / initiated 2020-04-20 / Terminated
FDA source (opens on fda.gov)

Suntech Medical, Inc. began a recall of Oscar 2, Model 250 System on . FDA classified it as Class II and gives the reason as "The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2429-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Suntech Medical, Inc.
Product
Oscar 2, Model 250 System
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall
The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.
FDA root cause
Process change control
Action
Suntech Medical Instruments, Inc. notified customers on about [DATE] via "URGENT: MEDICAL DEVICE RECALL" letter. Customers were informed that the device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg. Suntech Medical is instructing physicians and nurses that they can still use the device and are to ignore the readings on the device display and to continue to focus on the Accuwin Pro data for diagnosis. Best practice is to disable the device display during unit configuration and to instruct the patient to ignore any data that may be visible on the display. If these steps are followed, Suntech states the device can continue to be used. The correction will include 2 options: 1. To download the service tool at https://www.suntechmed.com/oscar2-display-update-request; or 2. Customers should contact SunTech to confirm the configuration has been corrected at [email protected] and provide the contact person, company name, and serial numbers of corrected devices. Additionally, customers were requested to complete and return the response form via email to [email protected], or they can be sent by mail to: Recall Coordinator, SunTech Medical, Inc., 507 Airport Blvd, suite 117, Morrisville, NC 27560-8200. Questions can be addressed to SunTech Medical at Email: [email protected], Phone: +1-800-421-8626 or 919-654-6128
Quantity in commerce
1,037 units
Distribution
Nationwide distribution to CA, CT, FL, IL, LA, MD, NC, NY, OH, PA, PR, SC, TN, TX, UT. Worldwide distribution to Australia, Austria, Belgium, Bermuda, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, Estonia, France, India, Ireland, Latvia, Lebanon, Morocco, Pakistan, Peru, Poland, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, United Kingdom, Vietnam.
Product codes and lots
Catalog Numbers (Serial Numbers): 99-0133-00 (SN:00101086, SN:00101159, SN:00101248, SN:00102173, SN:00107798, SN:00112277, SN:00113151, SN:00113262, SN:00113268, SN:00113279, SN:00113717, SN:00113838, SN:00114084, SN:00114513, SN:00115988, SN:00116238, SN:00116258, SN:00116331, SN:00116380, SN:00116384, SN:00116419, SN:00116423, SN:00116443, SN:00116445, SN:00116970, SN:00116974, SN:00116992, SN:00116993, SN:00117006, SN:00117017, SN:00117142, SN:00117160, SN:00117170, SN:00117926, SN:00117938, SN:00117941, SN:00117945, SN:00117952, SN:00117960, SN:00117968, SN:00118369, SN:00118370, SN:00118375, SN:00118382, SN:00118398, SN:00118403, SN:00118420, SN:00118428, SN:00118431, SN:00118541, SN:00118570, SN:00118698, SN:00118707, SN:00118728, SN:00118731, SN:00118741, SN:00118743, SN:00118914, SN:00118917, SN:00118919, SN:00118924, SN:00118926, SN:00118931, SN:00118932, SN:00118934, SN:00118940, SN:00121987, SN:00122088, SN:00122208, SN:00122209, SN:00122310, SN:00122350, SN:00122361, SN:00122365, SN:00122369, SN:00123475, SN:00123497, SN:00123503, SN:00124512, SN:00124516, SN:00124518, SN:00124530, SN:00124546, SN:00124585, SN:00124593, SN:00125141, SN:00125296, SN:00125302, SN:00125303, SN:00125305, SN:00125307, SN:00125308, SN:00125309, SN:00125310, SN:00125312, SN:00125313, SN:00125315, SN:00125317, SN:00125318, SN:00125319, SN:00125320, SN:00125321, SN:00125323, SN:00125325, SN:00125326, SN:00125330, SN:00125337, SN:00125339, SN:00125341, SN:00125342, SN:00125344, SN:00125345, SN:00125346, SN:00125348, SN:00125349, SN:00125350, SN:00125351, SN:00125353, SN:00125354, SN:00125356, SN:00125357, SN:00125358, SN:00125359, SN:00125360, SN:00125361, SN:00125362, SN:00125363, SN:00125365, SN:00125366, SN:00125367, SN:00125368, SN:00125369, SN:00125370, SN:00125371, SN:00125372, SN:00125373, SN:00125374, SN:00125375, SN:00125376, SN:00125377, SN:00125378, SN:00125379, SN:00125380, SN:00125381, SN:00125382, SN:00125383, SN:00125384, SN:00125385, SN:00125386, SN:00125387, SN:00125388, SN:00125389, SN:00125390, SN:00125397, SN:00125398, SN:00125399, SN:00125400, SN:00125402, SN:00125403, SN:00125405, SN:00125406, SN:00125407, SN:00125408, SN:00125409, SN:00125410, SN:00125411, SN:00125412, SN:00125413, SN:00125414, SN:00125415, SN:00125417, SN:00125418, SN:00125419, SN:00125420, SN:00125422, SN:00125423, SN:00125424, SN:00125425, SN:00125426, SN:00125427, SN:00125428, SN:00125429, SN:00125431, SN:00125432, SN:00125433, SN:00125435, SN:00125436, SN:00125439, SN:00125440, SN:00125442, SN:00125445, SN:00125447, SN:00125450, SN:00125451, SN:00125452, SN:00125455, SN:00125456,  SN:00125458, SN:00125460, SN:00125461, SN:00125465, SN:00125466, SN:00125467, SN:00125468, SN:00125469, SN:00125470, SN:00125471,  SN:00125472, SN:00125473, SN:00125474, SN:00125475, SN:00125476, SN:00125477, SN:00125478, SN:00125479, SN:00125480, SN:00125481,  SN:00125482, SN:00125483, SN:00125484, SN:00125485, SN:00125486, SN:00125487, SN:00125488, SN:00125489, SN:00125490, SN:00125491, SN:00125492, SN:00125493, SN:00125494, SN:00125495, SN:00125496, SN:00125497, SN:00125499, SN:00125500, SN:00125501, SN:00125502, SN:00125503, SN:00125504, SN:00125505, SN:00125506, SN:00125507, SN:00125508, SN:00125509, SN:00125510, SN:00125511, SN:00125512, SN:00125514, SN:00125515, SN:00125517, SN:00125518, SN:00125519, SN:00125520, SN:00125523, SN:00125525, SN:00125528, SN:00125530, SN:00125531, SN:00125532, SN:00125534, SN:00125535, SN:00125536, SN:00125537, SN:00125538, SN:00125539, SN:00125540, SN:00125541, SN:00125542, SN:00125543, SN:00125544, SN:00125545, SN:00125546, SN:00125547, SN:00125548, SN:00125549, SN:00125550, SN:00125551, SN:00125552, SN:00125553, SN:00125554, SN:00125555, SN:00125556, SN:00125557, SN:00125558, SN:00125559, SN:00125560, SN:00125561, SN:00125715, SN:00125717, SN:00125718, SN:00125719, SN:00125720, SN:00125721, SN:00125723, SN:00125724, SN:00125725, SN:00125726, SN:00125727, SN:00125728, SN:00125729, SN:00125730, SN:00125731, SN:00125732, SN:00125733, SN:00125734, SN:00125735, SN:00125737, SN:00125738, SN:00125739, SN:00125740, SN:00125741, SN:00125742, SN:00125743, SN:00125744, SN:00125745, SN:00125746, SN:00125747, SN:00125748, SN:00125749, SN:00125750, SN:00125751, SN:00125753, SN:00125754, SN:00125755, SN:00125756, SN:00125757, SN:00125758, SN:00125759, SN:00125760, SN:00125761, SN:00125762, SN:00125763, SN:00125764, SN:00125765, SN:00125766, SN:00125767, SN:00125768, SN:00125769, SN:00125770, SN:00125771, SN:00125773, SN:00125774, SN:00125775, SN:00125776, SN:00125777, SN:00125778, SN:00125779, SN:00125780, SN:00125781, SN:00125782, SN:00125783, SN:00125784, SN:00125785, SN:00125786, SN:00125787, SN:00125788, SN:00125789, SN:00125790, SN:00125791, SN:00125792, SN:00125793, SN:00125794, SN:00125795, SN:00125796, SN:00125797, SN:00125798, SN:00125799, SN:00125800, SN:00125801, SN:00125802, SN:00125803, SN:00125804, SN:00125805, SN:00125806, SN:00125807, SN:00125808, SN:00125809, SN:00125810, SN:00125811, SN:00125812, SN:00125813, SN:00125814, SN:00125816, SN:00125817, SN:00125818, SN:00125819, SN:00125820, SN:00125821, SN:00125822, SN:00125878, SN:00125879, SN:00125880, SN:00125881, SN:00125882, SN:00125883, SN:00125884, SN:00125885, SN:00125886, SN:00125887, SN:00125890, SN:00125891, SN:00125892, SN:00125893, SN:00125894, SN:00125895, SN:00125897, SN:00125899, SN:00125901, SN:00125902, SN:00125903, SN:00125904, SN:00125905, SN:00125906, SN:00125907, SN:00125908, SN:00125909, SN:00125910, SN:00125911, SN:00125912, SN:00125913, SN:00125914, SN:00125915, SN:00125916, SN:00125917, SN:00125918, SN:00125919, SN:00125920, SN:00125921, SN:00125922, SN:00125923, SN:00125924, SN:00125925, SN:00125926, SN:00125927, SN:00125928, SN:00125929, SN:00125930, SN:00125931, SN:00125932, SN:00125933, SN:00125934, SN:00125935, SN:00125936, SN:00125937, SN:00126066, SN:00126067, SN:00126068, SN:00126069, SN:00126070, SN:00126071, SN:00126072, SN:00126073, SN:00126074, SN:00126075, SN:00126076, SN:00126077, SN:00126078, SN:00126079, SN:00126080, SN:00126081, SN:00126082, SN:00126083, SN:00126084, SN:00126085, SN:00126086, SN:00126087, SN:00126088, SN:00126089, SN:00126090, SN:00126091, SN:00126092, SN:00126094, SN:00126095, SN:00126096, SN:00126097, SN:00126098, SN:00126099, SN:00126100, SN:00126101, SN:00126102, SN:00126103, SN:00126104, SN:00126105, SN:00126106, SN:00126107, SN:00126108, SN:00126109, SN:00126110, SN:00126111, SN:00126112, SN:00126113, SN:00126114, SN:00126115, SN:00126116, SN:00126117, SN:00126118, SN:00126119, SN:00126120, SN:00126121, SN:00126122, SN:00126123, SN:00126124, SN:00126125, SN:00126127, SN:00126128, SN:00126129, SN:00126130, SN:00126131, SN:00126132, SN:00126133, SN:00126134, SN:00126135, SN:00126137, SN:00126138, SN:00126139, SN:00126140, SN:00126141, SN:00126142, SN:00126143, SN:00126144, SN:00126145, SN:00126146, SN:00126147, SN:00126148, SN:00126149, SN:00126150, SN:00126151, SN:00126152, SN:00126153, SN:00126154, SN:00126155, SN:00126156, SN:00126157, SN:00126158, SN:00126159, SN:00126160, SN:00126161, SN:00126162, SN:00126163, SN:00126164, SN:00126165, SN:00126166, SN:00126167, SN:00126168, SN:00126169, SN:00126170, SN:00126171, SN:00126172, SN:00126174, SN:00126175, SN:00126177, SN:00126178, SN:00126179, SN:00126180, SN:00126181, SN:00126182, SN:00126183, SN:00126184, SN:00126185, SN:00126186, SN:00126187, SN:00126188, SN:00126189, SN:00126190, SN:00126191, SN:00126192, SN:00126193, SN:00126194, SN:00126195, SN:00126196, SN:00126197, SN:00126198, SN:00126199, SN:00126200, SN:00126201, SN:00126202, SN:00126203, SN:00126204, SN:00126205, SN:00126206, SN:00126207, SN:00126208, SN:00126209, SN:00126210, SN:00126211, SN:00126212, SN:00126213, SN:00126214, SN:00126215, SN:00126449, SN:00126450, SN:00126451, SN:00126452, SN:00126453, SN:00126454, SN:00126455, SN:00126456, SN:00126457, SN:00126458, SN:00126459, SN:00126460, SN:00126461, SN:00126462, SN:00126463, SN:00126464, SN:00126465, SN:00126466, SN:00126467, SN:00126468, SN:00126469, SN:00126470, SN:00126471, SN:00126472, SN:00126473, SN:00126474, SN:00126475, SN:00126476, SN:00126477, SN:00126478, SN:00126479, SN:00126480, SN:00126481, SN:00126482, SN:00126483, SN:00126484, SN:00126485, SN:00126486, SN:00126487, SN:00126488, SN:00126489, SN:00126490, SN:00126491, SN:00126492, SN:00126493, SN:00126494, SN:00126495, SN:00126496, SN:00126497, SN:00126498, SN:00126499, SN:00126500, SN:00126501, SN:00126502, SN:00126503, SN:00126504, SN:00126505, SN:00126506, SN:00126507, SN:00126508, SN:00126509, SN:00126510, SN:00126511, SN:00126512, SN:00126513, SN:00126514, SN:00126517, SN:00126518, SN:00126519, SN:00126520, SN:00126521, SN:00126522, SN:00126523, SN:00126524, SN:00126525, SN:00126526, SN:00126527, SN:00126528, SN:00126535, SN:00126536, SN:00126537, SN:00126538, SN:00126539, SN:00126540, SN:00126541, SN:00126542, SN:00126543, SN:00126544, SN:00126545, SN:00126546, SN:00126547, SN:00126548, SN:00126549, SN:00126550, SN:00126551, SN:00126552, SN:00126553, SN:00126554, SN:00126594, SN:00126595, SN:00126596, SN:00126598, SN:00126599, SN:00126600, SN:00126601, SN:00126602, SN:00126603, SN:00126604, SN:00126605, SN:00126606, SN:00126607, SN:00126608, SN:00126611, SN:00126612, SN:00126613, SN:00126614, SN:00126617, SN:00126618, SN:00126619, SN:00126620, SN:00126621, SN:00126622, SN:00126623, SN:00126624, SN:00126625, SN:00126626, SN:00126627, SN:00126759, SN:00126760, SN:00126761, SN:00126762, SN:00126763, SN:00126764, SN:00126766, SN:00126767, SN:00126768, SN:00126769, SN:00126770, SN:00126771, SN:00126772, SN:00126773, SN:00126774, SN:00126775, SN:00126776, SN:00126777, SN:00126778, SN:00126799, SN:00126800, SN:00126801, SN:00126802, SN:00126803, SN:00126804, SN:00126805, SN:00126806, SN:00126807, SN:00126809, SN:00126810, SN:00126811, SN:00126812, SN:00126813, SN:00126814, SN:00126815, SN:00126816, SN:00126817, SN:00126818, SN:00126819, SN:00126820, SN:00126821, SN:00126822, SN:00126823, SN:00126825, SN:00126826, SN:00126827, SN:00126828, SN:00126829, SN:00126830, SN:00126831, SN:00126832, SN:00126833, SN:00126834, SN:00126835, SN:00126836, SN:00126837, SN:00126838, SN:00126859, SN:00126860, SN:00126861, SN:00126862, SN:00126863, SN:00126864, SN:00126865, SN:00126866, SN:00126867, SN:00126868, SN:00126875, SN:00126876, SN:00126877, SN:00126878, SN:00127152, SN:00127616, SN:00127617, SN:00127619, SN:00127620, SN:00127644, SN:00127645, SN:00127646, SN:00127647, SN:00127651, SN:00127652, SN:00127654, SN:00127655, SN:00127658, SN:00127661, SN:00127683, SN:00127688, SN:00127689, SN:00127690, SN:00127695, SN:00127697, SN:00127700, SN:00127702);   99-0133-01 (SN:00115777, SN:00126374, SN:00127147, SN:00127148, SN:00127149, SN:00127150, SN:00127151, SN:00127153);   99-0133-02 (SN:00121249, SN:00122486, SN:00126376, SN:00127775, SN:00127776);   99-0133-03 (SN:00114191, SN:00116184, SN:00119788, SN:00127721, SN:00127722),   99-0133-10 (SN:00116330, SN:00118366, SN:00118371, SN:00118390, SN:00118422, SN:00118555, SN:00118565, SN:00118721, SN:00118928, SN:00124517, SN:00124928, SN:00125343, SN:00125347, SN:00125352, SN:00125355, SN:00125404, SN:00125416, SN:00125421, SN:00125430, SN:00125434, SN:00125438, SN:00125441, SN:00125443, SN:00125444, SN:00125446, SN:00125448, SN:00125449, SN:00125453, SN:00125454, SN:00125457, SN:00125462, SN:00125498, SN:00125521, SN:00125522, SN:00125524, SN:00125526, SN:00125527, SN:00125529, SN:00125533, SN:00125716, SN:00125736, SN:00125752, SN:00125772, SN:00125888, SN:00125889, SN:00125896, SN:00125898, SN:00125900, SN:00126173, SN:00126597, SN:00126615, SN:00127696);   99-0133-22 (SN:00112837, SN:00122038, SN:00122044, SN:00127710, SN:00127711, SN:00127712, SN:00127714);   99-0133-40 (SN:00113429, SN:00113459, SN:00113466, SN:00113480, SN:00117321, SN:00117327, SN:00121430, SN:00121435, SN:00121442, SN:00121446, SN:00121447, SN:00121448, SN:00121449, SN:00121466, SN:00121468, SN:00121470, SN:00121474, SN:00121481, SN:00121484, SN:00121485, SN:00121486, SN:00121488, SN:00121489, SN:00121490, SN:00121491, SN:00121492, SN:00121494, SN:00127146, SN:00127161, SN:00127162, SN:00127163, SN:00127164, SN:00127165, SN:00127166, SN:00127167, SN:00127169, SN:00127170, SN:00127171, SN:00127172, SN:00127173, SN:00127174, SN:00127175, SN:00127176, SN:00127177, SN:00127179, SN:00127180, SN:00127182, SN:00127183, SN:00127184, SN:00127185, SN:00127187, SN:00127189, SN:00127190, SN:00127192, SN:00127193, SN:00127194, SN:00127195, SN:00127196, SN:00127198, SN:00127199, SN:00127200, SN:00127202, SN:00127205, SN:00127207, SN:00127208, SN:00127209, SN:00127211, SN:00127212, SN:00127213, SN:00127214, SN:00127215, SN:00127216, SN:00127217, SN:00127218, SN:00127219, SN:00127220, SN:00127221, SN:00127222, SN:00127223, SN:00127229, SN:00127230, SN:00127231, SN:00127232, SN:00127233, SN:00127234, SN:00127235, SN:00127236, SN:00127237, SN:00127238, SN:00127239, SN:00127240, SN:00127241, SN:00127242, SN:00127243, SN:00127244, SN:00127245, SN:00127246, SN:00127247, SN:00127248, SN:00127249, SN:00127250, SN:00127251, SN:00127252, SN:00127253, SN:00127254, SN:00127255, SN:00127256, SN:00127257, SN:00127258, SN:00127260, SN:00127261, SN:00127262, SN:00127263, SN:00127264, SN:00127266, SN:00127267, SN:00127268, SN:00127269, SN:00127270, SN:00127271, SN:00127272, SN:00127273, SN:00127274, SN:00127275, SN:00127276, SN:00127277, SN:00127278, SN:00127279, SN:00127280, SN:00127281, SN:00127282, SN:00127283, SN:00127284, SN:00127285, SN:00127286, SN:00127287, SN:00127288, SN:00127289, SN:00127290, SN:00127291, SN:00127292, SN:00127293, SN:00127294, SN:00127295, SN:00127296, SN:00127297, SN:00127298, SN:00127299, SN:00127300, SN:00127701).

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2429-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2429-2020Class IITerminatedVoluntary: Firm initiated