Z-1313-2021 Class I Ongoing
FDA device recall Z-1313-2021 was initiated by Medtronic Perfusion Systems on March 3, 2021 and is designated Class I. Reason for recall: An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stop… The recall status is ongoing. Affected quantity: 387 devices (93 US).
Recall Details
- Product Type
- Devices
- Report Date
- April 7, 2021
- Initiation Date
- March 3, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 387 devices (93 US)
Product Description
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
Reason for Recall
An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.
Distribution Pattern
Worldwide distribution. US Nationwide including Puerto Rico, Brazil, Brunei Darussalam, Canada, China, Colombia, Croatia, Ecuador, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Korea, Mexico, Morocco, New Zealand, Russian Federation, Spain, Taiwan, Thailand, United Kingdom, and Viet Nam
Code Information
560BC: GTIN 00885074539386, Serial Numbers: 560B100094, 560B100212, 560B100244, 560B100257, 560B100274, 560B100283, 560B100418, 560B100439, 560B100482 560BC1: GTIN 00613994450326, Serial Numbers: 560B100901, 560B101368 560BCS: GTIN 00613994258236, Serial Numbers: 560B100369, 560B100376, 560B100472, 560B100495, 560B100496 560BCS1: GTIN: 00613994450463, Serial Numbers: 560B100191, 560B100690, 560B100783, 560B100806, 560B100820, 560B100871, 560B100896, 560B101062, 560B101187, 560B101318, 560B101344, 560B101470, 560B101499, 560B101504, 560B101519, 560B101593, 560B101526 GTIN 00613994526052, Serial Numbers: 560B102610, 560B102725 GTIN 00643169201033, Serial Numbers: 560B101838 GTIN 00643169201651, Serial Numbers: 560B101834 GTIN 00643169315822, Serial Numbers: 560B100127, 560B101694, 560B101700, 560B101805, 560B101976, 560B101996, 560B102080, 560B102118, 560B102185, 560B102194, 560B102204, 560B102210, 560B102215, 560B102265, 560B102336, 560B102426, 560B102493, 560B102518, 560B102547, 560B102559, 560B102598, 560B102761, 560B102762, 560B102763, 560B102764, 560B102765, 560B102766 GTIN 00763000135447, Serial Numbers: 560B102711, 560B102717, 560B102718, 560B102720, 560B102721, 560B102722, 560B102723, 560B102724, 560B102726, 560B102727, 560B102730, 560B102731, 560B102732, 560B102733, 560B102734, 560B102735, 560B102736, 560B102737, 560B102738, 560B102739, 560B102740, 560B102741, 560B102742, 560B102743, 560B102745, 560B102746, 560B102747, 560B102748, 560B102750, 560B102751, 560B102752, 560B102754, 560B102755, 560B102756, 560B102757, 560B102758, 560B102760, 560B102767, 560B102768, 560B102769, 560B102770, 560B102771, 560B102772, 560B102773, 560B102774, 560B102775, 560B102776 GTIN 00763000159412, Serial Numbers: 560B102930, 560B102931, 560B102932, 560B102933, 560B102934 GTIN 00763000236526, Serial Numbers: 560B102778, 560B102779, 560B102780, 560B102781, 560B102782, 560B102783, 560B102784, 560B102785, 560B102786, 560B102787, 560B102788, 560B102789, 560B102790, 560B102792, 560B102793, 560B102794, 560B102795, 560B102796, 560B102797, 560B102798, 560B102799, 560B102800, 560B102801, 560B102802, 560B102803, 560B102804, 560B102805, 560B102806, 560B102807, 560B102809, 560B102810, 560B102811, 560B102812, 560B102813, 560B102815, 560B102817, 560B102818, 560B102819, 560B102820, 560B102821, 560B102822, 560B102823, 560B102824, 560B102825, 560B102826, 560B102827, 560B102828, 560B102829, 560B102830, 560B102831, 560B102832, 560B102833, 560B102834, 560B102835, 560B102836, 560B102837, 560B102838, 560B102839, 560B102840, 560B102841, 560B102842, 560B102843, 560B102844, 560B102845, 560B102846, 560B102847, 560B102848, 560B102849, 560B102850, 560B102851, 560B102852, 560B102853, 560B102854, 560B102855, 560B102856, 560B102857, 560B102858, 560B102859, 560B102860, 560B102861, 560B102862, 560B102863, 560B102864, 560B102865, 560B102866, 560B102867, 560B102868, 560B102869, 560B102870, 560B102871, 560B102872, 560B102873, 560B102874, 560B102875, 560B102876, 560B102877, 560B102878, 560B102879, 560B102880, 560B102882, 560B102883, 560B102884, 560B102885, 560B102886, 560B102887, 560B102888, 560B102889, 560B102890, 560B102891, 560B102892, 560B102893, 560B102894, 560B102895, 560B102896, 560B102897, 560B102898, 560B102899, 560B102900, 560B102901, 560B102902, 560B102903, 560B102907, 560B102908, 560B102909, 560B102910, 560B102912, 560B102913, 560B102914, 560B102915, 560B102916, 560B102917, 560B102918, 560B102919, 560B102920, 560B102921, 560B102922, 560B102923, 560B102924, 560B102925, 560B102926, 560B102927, 560B102928, 560B102929, 560B102946, 560B102947, 560B102948, 560B102949, 560B102950, 560B102951, 560B102952, 560B102953, 560B102954, 560B102955, 560B102956, 560B102957, 560B102958, 560B102959, 560B102960, 560B102961, 560B102962, 560B102963, 560B102964, 560B102965, 560B102966, 560B102967, 560B102968, 560B102969, 560B102970, 560B102971, 560B102972, 560B102973, 560B102974, 560B102975, 560B102976, 560B102977, 560B102978, 560B102979, 560B102980, 560B102981, 560B102982, 560B102983, 560B102984, 560B102985, 560B102986, 560B102987, 560B102988, 560B102989, 560B102990, 560B102991, 560B102992, 560B102993, 560B102994, 560B102995, 560B102996, 560B102997, 560B102998, 560B102999, 560B103000, 560B103001, 560B103002, 560B103003, 560B103004, 560B103005, 560B103006, 560B103007, 560B103008, 560B103009, 560B103010, 560B103011, 560B103012, 560B103013, 560B103014, 560B103015, 560B103016, 560B103017, 560B103018, 560B103019, 560B103020, 560B103021, 560B103022, 560B103023, 560B103024, 560B103025, 560B103026, 560B103027, 560B103028, 560B103029, 560B103031, 560B103032, 560B103033, 560B103034, 560B103035, 560B103036, 560B103037, 560B103038, 560B103039, 560B103040, 560B103041, 560B103042, 560B103043, 560B103044, 560B103045, 560B103046, 560B103047, 560B103048, 560B103049, 560B103050, 560B103051, 560B103052, 560B103053, 560B103054, 560B103055, 560B103057, 560B103058, 560B103059, 560B103060, 560B103061, 560B103062, 560B103069, 560B103070, 560B103071, 560B103072, 560B103073, 560B103074, 560B103075, 560B103077, 560B103078, 560B103079 R560BCS1, GTIN 00643169315822, Serial Numbers: 560B102009, 560B102355, 560B102367