Z-1563-2024Class II
Ingenia 1.5T, Magnetic Resonance System
Philips North America LLC / initiated 2024-03-12 / Open, Classified / root cause: manufacturing process
Philips North America Llc began a recall of Ingenia 1.5T, Magnetic Resonance System on . FDA classified it as Class II and gives the reason as "Patient support table floor plate may be incorrectly installed". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1563-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips North America LLC
- Product
- Ingenia 1.5T, Magnetic Resonance System.
- Product code
- LNH System, Nuclear Magnetic Resonance Imaging
- Reason for recall
- Patient support table floor plate may be incorrectly installed.
- Root cause tag
- manufacturing process
- FDA root cause
- Process design
- Action
- Consignees were mailed an URGENT Medical Device Correction notice, dated 3/12/24. Consignees are instructed by the notice to identify affected systems, which can continue to be used with the provided instruction. If a patient's weight is at or near the maximum load of the device take care that they do not sit on the end of the tabletop opposite the bore entrance and that they do not hop down from their sitting position while the support is at its highest position. If the affected system has any unexpected movement or becomes unstable immediately stop use and contact your Philips representative for interim support. The recall notice is to be circulated to all users and the provided advisory displayed. Completed response forms are to be emailed to [email protected].
- Quantity in commerce
- 2,242 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.
- Product codes and lots
- Model No. 781396, 781315, 782115, 781341, 782101; UDI-DI 884838055322, 884838099715, 884838099043, 884838098275; Serial No. Serial Number, 70051, 84508, 84243, 41044, 84400, 84537, 41569, 41104, 41203, 41195, 70743, 87103, 70892, 41525, 84283, 70044, 41034, 84475, 84628, 87057, 41028, 84538, 84505, 41305, 70619, 84186, 70752, 61049, 41067, 41406, 41265, 41409, 70135, 70676, 70694, 70903, 84816, 41438, 41057, 41517, 41356, 84147, 41263, 41463, 41277, 84192, 61094, 70925, 41018, 70049, 61282, 84026, 84439, 84286, 41149, 70646, 70793, 70928, 70661, 41481, 87231, 84514, 84929, 61331, 84200, 70063, 41173, 41036, 87017, 70783, 41166, 84646, 84170, 70715, 41116, 70874, 70672, 41475, 41134, 41420, 41462, 41358, 84627, 61207, 70094, 84970, 41511, 70808, 41484, 41342, 61105, 84240, 84942, 41005, 70447, 41222, 87132, 84063, 41532, 41311, 84446, 41426, 84614, 84196, 41291, 41555, 87133, 41434, 41312, 84506, 70095, 70762, 41046, 41237, 84526, 84791, 84174, 41090, 41171, 41427, 84866, 70076, 84088, 41035, 84821, 70911, 70403, 41159, 41094, 70904, 84173, 70298, 84512, 70443, 87218, 41194, 87019, 84043, 84157, 84049, 41198, 41294, 41000, 41354, 70060, 70949, 84433, 84467, 70473, 70700, 41209, 84075, 70769, 61412, 61056, 70621, 41590, 84189, 70627, 87097, 41022, 84811, 70972, 84440, 41154, 70857, 41001, 84225, 41008, 41007, 41012, 41013, 41016, 41017, 41011, 41043, 41061, 41020, 41221, 84264, 70061, 41031, 41033, 41038, 41039, 41041, 70331, 41045, 41049, 41051, 41052, 41054, 41055, 84169, 41060, 41064, 41068, 41070, 41071, 41074, 41075, 84836, 41086, 41087, 41495, 70321, 41084, 41088, 41085, 84012, 41089, 41093, 41099, 41096, 41105, 41100, 41103, 41106, 41107, 41113, 41108, 41109, 41111, 41110, 70898, 41127, 41115, 41112, 84134, 41117, 41118, 41119, 41124, 41125, 41126, 41128, 41129, 41132, 41131, 41133, 41136, 41137, 41138, 41146, 41140, 41142, 41163, 41141, 41193, 41161, 41266, 41145, 41152, 41151, 41153, 41155, 41157, 41162, 41167, 41172, 41177, 41174, 41175, 41176, 41179, 41181, 41182, 41192, 41184, 41186, 41188, 41189, 41190, 41395, 41199, 41200, 41204, 41201, 41202, 41169, 41210, 41120, 41213, 41214, 41215, 41216, 41218, 41217, 41219, 41220, 41224, 41225, 41226, 41227, 41229, 41230, 41231, 41240, 41232, 41233, 41234, 41236, 41238, 41239, 41284, 41303, 41241, 41243, 41244, 41246, 41249, 41461, 41516, 41253, 41254, 41255, 41256, 41257, 41258, 41259, 41261, 41262, 41267, 41268, 41271, 41168, 41279, 41280, 41281, 41282, 41283, 41289, 41286, 41287, 41288, 41292, 41293, 41297, 41298, 41299, 41301, 41302, 41304, 41422, 41319, 70190, 41306, 41330, 41309, 41314, 41310, 41318, 41331, 41296, 41329, 41332, 41337, 41340, 41334, 41335, 41336, 41338, 41400, 41339, 61044, 41343, 41178, 41350, 41351, 41352, 41355, 41371, 41180, 41357, 41359, 41363, 41361, 41362, 41364, 41397, 41006, 41365, 41398, 41366, 41368, 41372, 41373, 41375, 41376, 41384, 41387, 41378, 41381, 41380, 41383, 41450, 41402, 41388, 41389, 41399, 41494, 41515, 41390, 41392, 41411, 41394, 41405, 41407, 41408, 41412, 41414, 41419, 41469, 41423, 41185, 41428, 41435, 41436, 41437, 41440, 41441, 41446, 41449, 41452, 41453, 41454, 41456, 70701, 41457, 41458, 41459, 41460, 41465, 41534, 41466, 41470, 41471, 41472, 41474, 41478, 41476, 41477, 41479, 41480, 41485, 41486, 41488, 41490, 41491, 41492, 41493, 41056, 41496, 41502, 41497, 41498, 41499, 41500, 41505, 41507, 41509, 41513, 41518, 41519, 41521, 41523, 41524, 41526, 41527, 41531, 41535, 41536, 41538, 41489, 41541, 41543, 41544, 41546, 41547, 41548, 41549, 84734, 41553, 41561, 41556, 41558, 41559, 41560, 70022, 70018, 70025, 70026, 70304, 70021, 41278, 41562, 41563, 41564, 41565, 70027, 70013, 41567, 70256, 41568, 70029, 41570, 70032, 84316, 70301, 41580, 41572, 70037, 70038, 70039, 41573, 41574, 41575, 70040, 70278, 41578, 70302, 70046, 70294, 70048, 84254, 70053, 70011, 41467, 41545, 70300, 70056, 70299, 70057, 70009, 70069, 70058, 70059, 70065, 70066, 70064, 70084, 70067, 41571, 70071, 70072, 70104, 41584, 70103, 70102, 70875, 70313, 70073, 70074, 41588, 70075, 41009, 70444, 70085, 70080, 70311, 70289, 70471, 70136, 84403, 61022, 70318, 41591, 70087, 70088, 70198, 70093, 70092, 70097, 41212, 70101, 41251, 70699, 41208, 70110, 70111, 70316, 70113, 70114, 70290, 70642, 70119, 70055, 70194, 70122, 70123, 41594, 70128, 70129, 70131, 41595, 70297, 70191, 70303, 70140, 70611, 70306, 70623, 70148, 70206, 84181, 84184, 61132, 70142, 70287, 70146, 70154, 70155, 70472, 70157, 70160, 70161, 70440, 70453, 70192, 70279, 70296, 70179, 70439, 70629, 61233, 70246, 70196, 70221, 70436, 70203, 70270, 70177, 70480, 70223, 70239, 70225, 70226, 70245, 70227, 70343, 41444, 70449, 70230, 70242, 70229, 70232, 70468, 70235, 70199, 70251, 41514, 70238, 70249, 70250, 70205, 70201, 70204, 70255, 70258, 70261, 70263, 70262, 70264, 70446, 70470, 70269, 70273, 70454, 70277, 70286, 70280, 70281, 70282, 70285, 84282, 70441, 70295, 70244, 70329, 70795, 70333, 70334, 70463, 70337, 70314, 70339, 70344, 70349, 70348, 70460, 70347, 70358, 70356, 70359, 70346, 70649, 70361, 70350, 70351, 70465, 70452, 70360, 41610, 70482, 70464, 70357, 70448, 70364, 70367, 70368, 70369, 84081, 70437, 70371, 70374, 70375, 70376, 70379, 70461, 70381, 70456, 70383, 70401, 70624, 70638, 70405, 70626, 70425, 70407, 70486, 70628, 70481, 70483, 70484, 70488, 70485, 70416, 70487, 70490, 70489, 70423, 70424, 70659, 70402, 70587, 70426, 70617, 70428, 70432, 70829, 70434, 70647, 70429, 70257, 70840, 70583, 70585, 61047, 70435, 70736, 70641, 70588, 70589, 70590, 70592, 70591, 70593, 70608, 70595, 70596, 70597, 70615, 70599, 70598, 41612, 70601, 70660, 70712, 70603, 70604, 70605, 84784, 70703, 70607, 87043, 70613, 70610, 70612, 70644, 70867, 70868, 70864, 70866, 70735, 70637, 70639, 70702, 70651, 70648, 70817, 70834, 70654, 70655, 70656, 70658, 70657, 70673, 70664, 70662, 70670, 70677, 70760, 70761, 70680, 70682, 84434, 70684, 84498, 70685, 70686, 41615, 41617, 70687, 70697, 70689, 70693, 70692, 70696, 70711, 70704, 70705, 70665, 70710, 70728, 70714, 70725, 84083, 70717, 70720, 70722, 70723, 70726, 70732, 70645, 41619, 70730, 70757, 70734, 70798, 70738, 70741, 70678, 70742, 41123, 70744, 70745, 70746, 70747, 70922, 70750, 70896, 70759, 70770, 61053, 70751, 70755, 70754, 70764, 70765, 70763, 70768, 70767, 70459, 70772, 70776, 70773, 70774, 70775, 70777, 70778, 70935, 70780, 70826, 84499, 70788, 70784, 70785, 70786, 70787, 70666, 70789, 70794, 70791, 70792, 70797, 70796, 61050, 70799, 70809, 70800, 70802, 70803, 70804, 70805, 70663, 70806, 70810, 70811, 70823, 70812, 70667, 70813, 84148, 84453, 70818, 70820, 70821, 70825, 70824, 70668, 70827, 70828, 70830, 70836, 70839, 70833, 70841, 70832, 70831, 70843, 70846, 70844, 70847, 70848, 70849, 70850, 70890, 70851, 70312, 70870, 70926, 70862, 70883, 70872, 70855, 70854, 70858, 70859, 70861, 84193, 84454, 70865, 70869, 70871, 70908, 70873, 70886, 70876, 70887, 70878, 70888, 70899, 70880, 70906, 70427, 70881, 70882, 70900, 84432, 70885, 70891, 70902, 70909, 70910, 70914, 70919, 70918, 70921, 70915, 70916, 70845, 70917, 70920, 70923, 70929, 70927, 70930, 70932, 70934, 70938, 70863, 70941, 70942, 70943, 70946, 70945, 70947, 70948, 70953, 70952, 70954, 41037, 70957, 70960, 70961, 70962, 70965, 70966, 70975, 41010, 70969, 70971, 70970, 84007, 70973, 70974, 70976, 84035, 70979, 70980, 70981, 70985, 70990, 70982, 84104, 70989, 70994, 84025, 70998, 84207, 70986, 70987, 70997, 70988, 84091, 70931, 84085, 70991, 70992, 84005, 70995, 84015, 84003, 84002, 84004, 84008, 84010, 84079, 84016, 84017, 84041, 84018, 84038, 84027, 84028, 84029, 84030, 84031, 87120, 84032, 84034, 84042, 84045, 84046, 84047, 41059, 84048, 41021, 84051, 84052, 84057, 84036, 84037, 84251, 84060, 84061, 84062, 84889, 70894, 84149, 84065, 84066, 84080, 84076, 84220, 84070, 84513, 41015, 84074, 84144, 84082, 84089, 84084, 84086, 84087, 84095, 84096, 84092, 70993, 84098, 84093, 84110, 84099, 84194, 84109, 84102, 84206, 41098, 84108, 84039, 84371, 41079, 84154, 70691, 84272, 84429, 84113, 84191, 84114, 84115, 84116, 41148, 84118.84130, 41048, 84150, 84185, 84295, 84122, 84127, 84378, 84124, 84166, 84164, 84165, 84167, 84125, 84126, 84129, 84138, 84140, 84131, 84346, 84377, 70636, 84145, 84136, 84135, 84137, 84293, 84141, 41029, 84162, 84177, 84172, 84281, 84175, 84176, 84171, 84187, 84197, 84294, 84199, 84195, 84208, 84201, 84203, 84202, 84205, 84204, 84216, 84979, 84211, 84218, 84210, 84209, 84334, 84212, 84228, 84214, 84217, 84219, 84221, 84198, 84230, 41095, 84229, 84450, 84234, 84231, 84238, 84233, 84237, 84239, 84069, 84245, 84241, 84178, 84242, 84247, 84248, 84253, 84249, 84250, 84252, 84256, 84255, 84469, 84261, 84259, 84275, 84179, 84262, 84532, 84271, 84266, 84541, 84267, 84268, 84269, 41092, 84270, 84278, 84276, 84509, 84292, 84288, 84287, 84290, 84298, 84289, 84180, 84674, 84291, 84343, 84297, 84396, 84306, 84307, 84444, 84305, 84313, 84021, 84244, 84310, 84308, 84142, 84329, 84309, 84312, 84311, 84315, 84318, 84401, 84325, 84319, 41197, 84321, 84320, 84347, 84323, 84322, 41250, 84333, 84332, 84327, 84328, 70933, 84331, 84341, 84335, 84338, 84339, 84342, 84279, 84355, 84352, 84351, 84354, 84349, 84353, 84350, 84300, 84363, 84357, 84361, 84359, 84360, 84362, 84367, 84369, 84376, 84372, 84374, 84375, 41160, 84379, 84302, 84382, 84383, 84380, 84445, 84397, 84389, 84392, 84388, 84500, 84406, 84399, 84398, 84394, 84395, 84402, 84404, 84407, 84408, 84381, 84422, 84425, 84409, 84416, 84413, 84411, 84419, 84412, 84423, 84530, 84420, 84414, 84431, 84415, 84437, 84459, 84430, 84417, 84502, 84427, 84802, 84421, 84330, 84424, 84303, 70451, 84750, 41442, 84448, 84443, 84477, 84458, 84456, 84455, 84451, 84452, 84471, 84470, 84473, 84474, 84476, 84479, 84480, 70733, 84482, 84483, 84488, 84489, 84496, 84497, 84384, 41066, 84492, 84494, 84520, 84518, 84521, 84519, 84524, 84523, 84522, 84257, 84507, 84491, 84536, 84495, 84503, 84510, 84515, 84517, 84544, 84516, 41421, 84525, 84528, 84527, 84529, 84531, 84387, 84533, 84534, 84535, 84539, 84629, 84545, 84546, 84547, 84551, 84549, 84613, 84554, 84555, 84566, 84557, 84564, 84565, 84556, 84558, 84560, 84571, 84572, 84577, 84712, 84568, 84573, 84569, 84575, 84574, 61342, 41415, 84935, 84576, 84581, 84582, 84593, 84584, 84583, 84585, 84587, 84594, 84606, 84588, 84608, 84591, 84592, 84599, 84604, 84596, 84598, 84714, 84603, 84605, 87055, 84649, 70062, 70438, 41551, 84611, 84648, 84612, 84600, 84602, 84620, 84621, 84624, 84626, 84630, 84632, 84634, 84635, 84637, 84652, 84640, 84641, 84741, 70606, 84644, 84645, 70650, 84633, 84651, 84647, 84616, 84650, 70308, 84654, 70445, 84655, 84656, 84657, 70050, 84746, 84661, 84667, 84663, 84664, 84666, 84668, 84669, 84670, 84671, 84690, 84385, 84673, 70442, 84748, 84675, 84676, 84677, 84678, 84679, 84680, 70259, 84686, 84681, 84694, 84693, 84692, 84723, 84689, 84687, 84659, 84695, 84697, 84705, 84704, 84706, 84716, 70052, 84708, 84713, 84660, 84719, 84720, 41091, 84718, 84717, 84733, 84721, 84722, 84700, 84724, 70042, 84725, 84726, 84729, 84768, 41417, 84662, 70455, 84738, 84736, 41429, 84777, 84776, 84778, 84779, 84781, 84780, 84782, 84783, 84740, 70328, 84742, 84745, 70292, 84747, 84752, 84751, 84775, 61384, 84994, 84851, 84744, 84730, 70698, 70675, 84772, 70635, 84806, 84792, 84756, 84755, 84807, 84757, 84918, 84758, 84767, 84759, 84771, 84770, 84766, 70719, 84765, 70727, 70707, 70706, 70724, 84773, 84774, 84787, 84788, 84829, 84789, 84597, 84790, 84864, 41473, 84892, 84893, 84937, 87092, 84804, 84795, 84793, 84995, 84871, 84803, 84801, 84796, 84617, 84798, 84809, 84805, 84810, 84812, 84813, 70819, 84818, 84819, 84820, 84822, 84826, 70674, 70690, 84869, 84825, 84838, 84854, 84832, 84830, 84831, 84642, 84833, 84842, 84837, 84839, 84855, 84844, 84845, 84847, 84848, 84849, 84850, 84852, 84858, 84857, 84859, 84861, 70749, 84862, 84863, 84865, 84867, 84872, 70771, 84873, 70709, 84881, 84879, 84880, 84882, 84885, 84888, 84828, 84890, 84808, 84891, 84895, 84896, 84913, 84914, 84915, 70893, 70963, 84910, 84900, 84901, 84904, 84905, 84908, 84909, 70156, 41552, 84921, 84920, 84922, 84952, 84916, 70939, 41023, 84917, 70801, 84428, 84940, 84928, 84930, 84931, 84933, 84934, 84939, 84943, 84946, 84947, 84948, 84168, 84956, 87229, 87228, 84955, 84960, 84969, 84965, 84975, 84977, 84978, 70779, 84982, 84983, 84827, 84984, 84986, 84987, 84988, 70195, 70614, 84997, 84989, 84653, 84990, 41077, 84077, 84996, 87001, 87005, 87000, 87003, 87004, 84853, 41418, 84976, 87009, 87022, 87008, 87023, 87036, 87037, 87024, 87027, 87026, 87029, 87031, 87044, 87035, 87034, 84274, 87038, 84868, 87039, 70977, 87045, 87048, 87054, 87049, 87050, 87056, 87058, 41228, 41211, 87068, 87079, 87076, 87069, 87071, 41205, 84552, 84222, 70729, 87081, 87083, 87078, 87082, 87084, 87101, 87090, 87086, 87087, 87095, 87094, 87121, 87102, 87110, 87109, 87111, 87112, 87113, 87114, 87115, 87117, 87119, 87131, 87129, 87141, 87134, 87139, 87136, 87147, 87138, 87151, 87142, 87143, 87144, 84410, 87146, 87028, 87123, 87152, 87153, 87154, 87161, 87155, 87158, 87255, 87163, 87165, 84460, 87171, 70951, 87172, 87174, 87175, 87176, 87181, 87195, 87185, 87187, 87188, 87194, 87190, 87191, 87192, 87209, 87202, 87219, 87201, 84441, 87196, 87197, 61005, 61004, 61003, 61001, 61007, 61008, 61011, 61009, 87210, 61066, 61065, 87204, 61013, 61063, 61062, 87214, 87215, 61014, 87211, 61016, 87208, 61017, 87213, 87212, 84834, 61002, 61018, 61019, 61020, 61006, 61023, 61024, 61025, 61026, 61027, 61015, 61028, 87224, 87232, 61029, 61030, 87266, 61031, 87247, 61032, 87227, 87226, 61033, 61034, 61035, 87233, 61058, 87235, 87236, 61045, 87234, 61036, 87240, 87241, 87237, 87238, 87239, 61037, 87242, 61038, 87260, 61039, 61041, 61040, 61042, 61043, 87244, 61046, 87248, 87249, 61051, 84067, 87252, 61052, 61054, 61055, 84709, 61101, 87254, 61059, 87257, 61057, 87259, 61060, 84682, 70937, 61061, 61064, 61096, 87279, 61075, 70271, 61067, 87265, 61076, 61068, 61069, 70236, 61123, 61070, 61072, 61079, 87281, 61097, 87268, 61074, 61073, 87269, 84481, 87278, 87277, 84280, 61084, 61082, 61078, 61080, 61085, 87272, 61087, 87274, 61088, 84484, 84485, 61092, 61091, 61093, 61102, 61103, 61095, 87282, 41425, 87283, 61106, 61107, 61108, 61109, 61114, 87284, 87285, 87291, 87289, 61124, 61119, 61125, 61117, 61116, 61115, 87601, 87294, 87296, 84911, 84824, 84823, 61126, 61129, 61130, 87299, 87607, 87610, 87608, 61131, 87300, 87605, 87609, 84954, 61138, 61175, 61185, 61184, 61188, 41097, 61195, 61192, 61193, 61191, 61187, 61179, 61189, 61181, 61176, 87602, 61186, 61182, 61178, 61198, 61199, 61200, 61183, 61203, 61140, 61202, 61180, 87302, 61142, 61177, 61275, 61204, 61206, 61205, 87303, 61208, 61210, 87305, 61209, 61212, 61211, 61213, 61227, 87276, 61218, 61143, 87307, 61240, 61219, 61220, 61221, 61223, 61222, 61224, 61225, 61228, 61226, 61264, 61231, 61234, 61260, 61259, 87613, 61235, 61144, 87311, 61236, 87312, 61237, 61238, 87614, 61248, 61249, 87245, 61256, 61214, 61246, 61243, 87314, 61286, 61245, 61250, 87315, 61252, 61253, 41083, 61274, 61258, 61257, 61284, 61261, 61262, 61312, 61311, 61310, 41206, 41313, 61263, 87617, 41512, 61266, 61265, 61268, 61269, 61270, 61271, 70835, 61273, 87317, 87318, 61276, 61279, 61281, 87319, 61288, 61294, 61293, 41003, 61287, 61289, 41242, 61292, 61295, 87320, 61112, 61298, 61299, 61300, 61201, 61306, 61383, 61303, 61304, 41158, 61232, 61313, 61314, 61315, 41260, 61316, 70233, 61321, 61320, 61317, 61319, 41290, 70200, 61327, 61326, 61328, 61329, 61330, 61332, 61334, 61336, 61337, 61338, 61216, 61341, 61348, 61351, 61356, 61352, 61360, 61357, 87326, 61358, 61242, 87633, 61359, 61285, 87636, 41073, 61377, 61406, 61378, 61280, 61302, 61380, 61272, 87632, 87639, 61381, 61382, 61386, 61390, 61350, 61283, 87644, 87638, 61385, 87649, 87631, 87641, 87627, 87642, 61394, 87643, 61395, 61397, 61401, 61403, 61404, 84462, 84973, 61407, 61291, 84340, 84993, 70758, 84344, 61416, 61417, 61420, 61421, 61419, 61415.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1550-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1551-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1552-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1553-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1554-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1555-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1556-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1557-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1558-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1559-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1560-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1561-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1562-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1563-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1564-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1565-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1566-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1567-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1568-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1569-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1570-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1571-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1572-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1573-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1574-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1575-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1576-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1577-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1578-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1579-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1580-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1581-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1582-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1583-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1584-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1585-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1586-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1587-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1588-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1589-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1590-2024 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.