Recall Z-0586-2019 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
| Date | Sep 11, 2018 |
| Status | Open, Classified |
| Reason | Patient monitors may restart due to network overload caused by network configuration. |
| Root cause | Software design |
| Action | The recalling firm, GE Healthcare, issued "URGENT MEDICAL DEVICE CORRECTION" letters dated 9/11/2018 via trackable mail on 9/11/2018 to its customers. The letters described the product, problem and actions to be taken. The letters informed the customer of the issue and providing safety instructions for mitigation of the issue if a prolonged network overload occurs and the Bx0 and/or B1x5 patient monitor on the network does not resume normal functionality in approximately 90 seconds. The customers were instructed to follow the safety instructions. GE Healthcare will provide revised network |
| Quantity | 6,864 patient monitors |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belgium, Bolivia, Bosnia-Herzegovina, Brazil, Brunei, Bulgaria, Burma (Myanmar), Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143676 | B40i Patient Monitor GE Healthcare Finland Oy, Jul 31, 2015 |