Recall Z-0958-2015 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Invivo Corporation
Philips Expression MR200 MRI Patient Monitoring System.
| Date | Jan 13, 2015 (initiated Oct 22, 2014) |
| Status | Terminated |
| Reason | The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock. |
| Root cause | Component design/selection |
| Action | Philips Medical Systems sent an Urgent - Medical Device Correction Letter dated October 22, 2014, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Our records indicate that you have an affected device. The following page provides additional instructions and actions that will be taken to address this problem. If you need any further information or support concerning this issue, please contact your local Philips representative: 877-468-4861 option 1, then option 2. |
| Quantity | 20 |
| Distribution | CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131382 | EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL Invivo Corporation, Jul 15, 2013 |