Philips Expression MR200 MRI Patient Monitoring System.
This recall has been terminated (originally issued January 13, 2015).
- Company
- Invivo Corporation
- Recall Initiated
- October 22, 2014
- Posted
- January 13, 2015
- Terminated
- January 9, 2017
- Recall Number
- Z-0958-2015
- Quantity
- 20
- Firm Location
- Orlando, FL
- Official Source
- View on FDA website ↗
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.
Distribution
CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.
Lot / Code Info
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.
Root 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.