Philips Recalls MRI Patient Monitoring Systems Due to Incorrect Calibration Instructions
Philips is recalling 2,214 MRI Patient Monitoring Systems because the instructions for oxygen sensor calibration are incorrect for specific software versions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a documentation error (incorrect instructions) rather than a direct physical defect causing injury, fitting the Moderate category for minor labeling or documentation issues.
Plain-English summary
Philips North America, LLC is recalling 2,214 units of the Expression MR400 MRI Patient Monitoring System (Model Number 866185). The recall affects devices running software versions 01.03.00, 01.04.00, 01.05.00, and 01.07.00. These systems are 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.
The recall was initiated because menu selections for users to access the oxygen (O2) sensor calibration were changed but 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 the affected software revisions.
The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries such as Canada, the United Kingdom, Germany, and Japan. Healthcare professionals using these devices should consult the recall notice for specific instructions on how to proceed with calibration or contact the manufacturer for guidance.
The recalled product
- 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…
- Manufacturer
- Philips North America, LLC
- Affected units
- 2,214
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Software version number: 01.03.00
- 01.04.00
- 01.05.00
- and 01.07.00
Distribution
Distributed nationwide across the United States.
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