# FDA recall Z-1616-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-02-20.

## 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

## Distribution

Worldwide distribution - US Nationwide distribution and countries of Utd Arab Emir, Albania, Austria,   Australia, Azerbaijan, Bulgaria, Brazil, White Russia, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary,   Ireland, Israel, India, Iceland, Italy, Jamaica, Japan, Kyrgyzstan, Malaysia, Netherlands, Norway, Oman,   Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Uzbekistan, Viet Nam.

## Key facts

- **Recall number:** Z-1616-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-20
- **Report date:** 2020-04-08
- **Termination date:** 2021-09-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1616-2020

## Citation

> AI Analytics. FDA recall Z-1616-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1616-2020. Source: US FDA. Licensed CC0.

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