Z-1616-2020Class II

Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00...

Name: Z-1616-2020 Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00...
Creator: Philips North America, LLC
Published: 2020-02-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-02-20 / Terminated / root cause: labeling and UDI

FDA source

Philips North America, LLC began a 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 - Product Usage: The... on 2020-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1616-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-20
Posted: 2020-03-31
Terminated: 2021-09-21
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.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1616-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1616-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-31

Product code MWI

K152330Class IIExpression MR400 MRI Patient Monitoring SystemInvivo Corporation / cleared 2015-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)