Expression MR400 MRI Patient Monitoring System Model Number: 866185… — Class II medical device recall Z-1616-2020
Terminated recall by Philips North America, LLC, reported 2020-04-08, distributed nationwide. Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into
| Recall number | Z-1616-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2020-02-20 |
| Classified | 2020-03-31 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2021-09-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BG, BR, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IS, IT, JM, JP, MY, NL, NO, OM, PE, PL, PT, QA, RO, RU, SA, SE, SG, SI, TH, VN |
| Quantity | 2,214 units |
| Reason classes | software |
| Model numbers | 866185, MR400MRI |
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 for recall
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
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-1616-2020. 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.