Recall Z-0958-2015
Invivo Corporation · initiated October 22, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Philips Expression MR200 MRI Patient Monitoring System.
Codes / lots: Model No. 866120; Lot/ Serial Numbers: US33600065, US33600066, US33600075, US33600077, US33600078, US33600079; US33600080, US33600081, US33600082, US33600083, US33600084, US33600086, US33600087, US33600088, US33600089, US33600090, US33600091, US33600092, US33600093, US33600094.
Reason for recall
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.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-0958-2015
- Initiated
- October 22, 2014
- Posted by FDA
- January 13, 2015
- Terminated
- January 9, 2017
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Quantity
- 20
- Distribution
- CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.
- Recalling firm
- Invivo Corporation, Orlando, FL