Recall Z-0069-2015 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Invivo Corporation
Philips Expression MR200 MRI Patient Monitoring System
| Date | Oct 15, 2014 (initiated Sep 5, 2014) |
| Status | Terminated |
| Reason | Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. |
| Root cause | Process control |
| Action | Philips Medical Systems sent an Urgent - Medical Device Correction letter dated July 9, 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 | 24 units. |
| Distribution | Worldwide Distribution - US including the states of CA, GA, MI, NJ, NV, and TX., and the countries of: Austria, Finland, Germany, Poland, Singapore, Sweden, Switzerland 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 |