Medical Device Alert: Philips Ingenia MRI Tabletop Movement Failure
Philips Ingenia 3.0T MRI systems may fail to move the patient tabletop completely in or out, potentially delaying patient evacuation and treatment. 266 units are affected worldwide.
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: FDA Class II recall. The device malfunction presents a risk of patient evacuation delay and treatment postponement in a medical imaging setting, without reported injuries. This meets the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 266 Ingenia 3.0T CX-a Magnetic Resonance (MRI) systems due to a malfunction in the patient tabletop movement mechanism.
When the system is operated in manual mode, the tabletop may not completely move in or out of the MRI bore. This failure could delay patient evacuation from the imaging chamber and postpone necessary treatment.
The affected systems have been distributed worldwide, including throughout the United States. Healthcare facilities using these systems should be aware of this issue.
The recalled product
- Product
- Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models…
- Manufacturer
- Philips North America Llc
- Affected units
- 266
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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