Philips Expression MR200 MRI Patient Monitoring System — Class II medical device recall Z-0958-2015
Terminated recall by Invivo Corporation, reported 2015-01-21, distributed in CA, FL, IN, KY, MN, NC, NJ, NY…. The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss o
| Recall number | Z-0958-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invivo Corporation, Orlando, FL, United States |
| Recall initiated | 2014-10-22 |
| Classified | 2015-01-13 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2017-01-09 |
| Distributed | CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD, TX |
| Countries outside the US | GB, NL, PL |
| Quantity | 20 |
| Serial numbers | US33600065, US33600066, US33600075, US33600077, US33600078, US33600079, US33600080, US33600081, US33600082, US33600083, US33600084, US33600086, US33600087, US33600088, US33600089, US33600090, US33600091, US33600092, US33600093, US33600094 |
| Model numbers | 866120 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0958-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.