—#180059

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.

FDA product code: MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K152330
Affected lot / code info: Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00

Why it was recalled

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 (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-02-20
Terminated: 2021-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180059. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.