Philips Expression MR200 MRI Patient Monitoring System Model 866120 — Class II medical device recall Z-0001-2015
Terminated recall by Invivo Corporation, reported 2014-10-08, distributed in CA. During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device'
| Recall number | Z-0001-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invivo Corporation, Orlando, FL, United States |
| Recall initiated | 2014-09-08 |
| Classified | 2014-10-01 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2017-01-09 |
| Distributed | CA |
| Countries outside the US | PL, SE, SG |
| Quantity | 10 units |
| Lot numbers | US33600006, US33600007, US33600011, US33600012, US33600013 |
| Model numbers | 866120 |
Product
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Reason for recall
During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.
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-0001-2015. 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.