Recall Z-2245-2020 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Philips North America, LLC
Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for
| Date | Apr 13, 2020 |
| Status | Terminated |
| Reason | The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex. |
| Root cause | Under Investigation by firm |
| Action | In March of 2020 Philips Healthcare sent out an Urgent Medical Device Corrective Action Notice identifying the problem, under what circumstances it can occur, the actions that should be taken by the customer/user to prevent risks for patients/users, and the actions planned by Philips to correct the problem. PRODUCTS: All Pneumograph, chest, NM, 3160 with part #94023 are affected. ACTIONS TO BE TAKEN: Customers/users are asked to review the Notification letter and share with all members of staff who utilize this product. Customers/Users should also retain a copy with the equipment Instructio |
| Quantity | 1075 Units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080038 | VANTAGE TITAN, MODEL MRT-1504/S3 Toshiba America Medical Systems, In.C, Jan 22, 2008 |