Z-0958-2015 Class II Terminated
FDA device recall Z-0958-2015 was initiated by Invivo Corporation on October 22, 2014 and is designated Class II. 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. The recall status is terminated (terminated January 9, 2017). Affected quantity: 20.
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2015
- Initiation Date
- October 22, 2014
- Termination Date
- January 9, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
Philips Expression MR200 MRI Patient Monitoring System.
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 Pattern
CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.
Code Information
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.