Recall Z-2810-2020 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Philips North America, LLC
Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.
| Date | Jun 18, 2020 |
| Status | Terminated |
| Reason | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger. |
| Root cause | Nonconforming Material/Component |
| Action | Philips Healthcare sent a customer notification letter dated June 2020 explaining the potential issues observed with their products. This letter instructs the consumer to contact the company with any reports of issues associated with this failure. |
| Quantity | 24,545 Units |
| Distribution | World wide distribution. Firm reports distributing more product then quantity manufactured. Clarification requested. And received. Firm made error in counting number of batteries distributed. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090785 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 Invivo Corp., Dec 15, 2009 |