FDA Medical Device Recalls (openFDA)
Philips North America, LLC: 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.
- Recall number
- Z-1616-2020
- Recalling firm
- Philips North America, LLC
- 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.
- Status
- Terminated
- Initiated
- 2020-02-20
- Posted
- not on file
- Terminated
- 2021-09-21
- 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
- Root cause
- Labeling design
- Action
- Philips issued to U.S. customers letter on 2/20/20 via priority mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall ,health risk and action to e taken: Customer/User section of the Customer Information Letter: Included with this Customer Information letter is an Instruction for Use addendum (Part Number 453564720941; Revision B) which provides correct instructions for accessing the O2 sensor calibration menu, as well as other updated product information. Please ensure that the information contained in the addendum is communicated to all users and servicers and is retained with the MR400 Instructions for Use. Upon fulfilling these actions, please complete and sign the attached Reply Form and return it to Philips as directed. Information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377. The firm identified additional accounts and initiated a mailing of the letter on 3/18/20.
- Quantity
- 2214 units
- 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.
- Lot, serial or model codes
- Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00
- 510(k) numbers
- ["K152330"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28