FDAFDA · Food and drugs·Recall number Z-1616-2020
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.
Published April 8, 2020 · Recall initiated: February 20, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Philips North America, LLC
- Distributor
- 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.
- Lot
- Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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