MRI System Patient Support Table Floor Plate Installation Defect
Philips Ingenia 3.0T CX MRI systems may have an incorrectly installed patient support table floor plate. This installation error could compromise the stability of the patient support table during use.
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 is an FDA Class II medical device recall involving a structural installation defect on patient support equipment. Although no reported injuries are mentioned in the source text, the potential for patient injury from an unstable support table represents a risk-of-harm scenario that qualifies as High severity per the rubric.
Plain-English summary
Philips North America LLC is recalling the Ingenia 3.0T CX Magnetic Resonance System due to a potential installation defect. The patient support table floor plate may be incorrectly installed on affected units.
An incorrectly installed floor plate could compromise the stability and safe operation of the patient support table, potentially creating a hazard for patients during MRI procedures.
The recall affects approximately 342 units of the Ingenia 3.0T CX distributed worldwide, including throughout the United States and numerous other countries. Healthcare facilities and imaging centers with affected systems should contact Philips North America LLC immediately to verify the floor plate installation status of their equipment and arrange for inspection and correction if necessary.
The recalled product
- Product
- Ingenia 3.0T CX, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 342
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 (20)
- Model No. 781271
- 782105
- UDI-DI 884838068452
- 884838098312
- Serial No. 78000
- 78003
- 78004
- 78005
- 78007
- 78035
- 78062
- 78010
- 78009
- 78011
- 78012
- 78014
- 78013
- 78015
- 78016
- 78017
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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