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.

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

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.