Class 2 Device Recall Expression MR400 MRI Patient Monitoring System

• Date Initiated by Firm: February 20, 2020
• Create Date: March 31, 2020
• Recall Status: Terminated on September 21, 2021
• Recall Number: Z-1616-2020
• Recall Event ID: 85090
• 510(K)Number: K152330
• Product Classification: Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
• 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.
• Code Information: Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00
• Recalling Firm/ Manufacturer: Philips North America, LLC; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer 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
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MWI and Original Applicant = INVIVO CORPORATION