FDA Device recall Z-0958-2015
Philips Expression MR200 MRI Patient Monitoring System
- FDA Device
- Class II
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class II recall of Philips Expression MR200 MRI Patient Monitoring System by Invivo, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0958-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-22 |
| Published | 2015-01-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Invivo |
| Distribution | CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD, TX |
Product
Philips Expression MR200 MRI Patient Monitoring System.
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.
Identifiers
| code_info | Model No. 866120; Lot/ Serial Numbers: US33600065, US33600066, US33600075, US33600077, US33600078, US33600079; US336000…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0958-2015%22
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