Reported Apr 8, 2020 · Terminated
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00,…
Philips North America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Expression MR400 MRI
- Patient Monitoring System Model Number866185
- Software version number
01.03.0001.04.0001.05.00and 01.07.00 -
- Product UsageThe 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
- Lot codes and dates
- Software version number
01.03.0001.04.0001.05.00and 01.07.00
- Software version number
- Amount recalled
- 2214 units
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
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