FDA Device recall Z-1616-2020
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - P…
- FDA Device
- Class II
- terminated
- Published 2020-04-08
On 2020-04-08 the FDA classified a Class II recall of Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - P… by Philips North America, citing menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1616-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-20 |
| Published | 2020-04-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intended for use by healthcare professionals to monitor vital signs of patients undergoing MRI procedures and to provide signals for the synchronization of the MRI scanner.
Reason
Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing the O2 sensor calibration are incorrect for customers performing this task with an MR400 device with software revisions: 01 .03.00, 01.04.00, 01 .05.00 and 01 .07.00
Identifiers
| code_info | Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1616-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.