Philips Evolution 3.0T MRI System patient table floor plate installation defect
Philips Evolution 3.0T MRI systems may have an incorrectly installed patient support table floor plate, creating a potential safety risk. Affected facilities should verify proper installation.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall is scored as High based on FDA Class II classification with a risk-of-harm product and no reported illnesses or injuries. The potential for patient injury from an unstable table supports this severity despite the absence of incident reports.
Plain-English summary
Philips North America LLC is recalling certain Evolution Upgrade 3.0T Magnetic Resonance Systems (MRI systems) due to a potential installation defect affecting the patient support table floor plate.
The patient support table floor plate may be incorrectly installed on these systems. This incorrect installation creates a potential safety risk to patients during use of the MRI system.
The recall affects units worldwide, including locations in the United States and numerous other countries. Facilities and medical centers using affected Evolution Upgrade 3.0T systems should verify that the patient support table floor plate is correctly installed. If an incorrectly installed floor plate is identified, contact Philips North America LLC for guidance on proper installation or replacement.
The recalled product
- Product
- Evolution Upgrade 3.0T, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 1
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 (3)
- Model No. 782143
- UDI-DI n/a
- Serial No. 85699.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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