FDA Device recall Z-0001-2015
Philips Expression MR200 MRI Patient Monitoring System Model 866120
- FDA Device
- Class II
- terminated
- Published 2014-10-08
On 2014-10-08 the FDA classified a Class II recall of Philips Expression MR200 MRI Patient Monitoring System Model 866120 by Invivo, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0001-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-08 |
| Published | 2014-10-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Invivo |
| Distribution | CA |
Product
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Reason
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.
Identifiers
| code_info | Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0001-2015%22
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