Recall Z-1616-2020— Philips North America, LLC

Name: FDA recall Z-1616-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-20

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-02-20, terminated 2021-09-21. It names one FDA 510(k) clearance: K152330. 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.. 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.

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-02-20
Terminated: 2021-09-21
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K152330 — Expression MR400 MRI Patient Monitoring SystemInvivo Corporation·cleared 2015-12-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.