MRI device tabletop may fail to move completely in manual mode
Philips Ingenia MRI tabletops may fail to move completely in manual mode, potentially delaying patient evacuation. The recall affects 144 units 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 with no reported illnesses or injuries. The hazard is mechanical malfunction with potential for patient evacuation delay, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 144 units of the Ingenia 1.5T S-a Magnetic Resonance System (Model 78137), a diagnostic imaging device used to create cross-sectional and spectroscopic images of the body.
The patient tabletop in these MRI systems may fail to move completely into or out of the scanner bore when operated in manual mode. This defect could delay patient evacuation from the device and potentially delay treatment.
The affected units have worldwide distribution, including throughout the United States.
Healthcare facilities that operate affected devices should contact Philips North America LLC for instructions on how to address this issue.
The recalled product
- Product
- Ingenia 1.5T S-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 Model…
- Manufacturer
- Philips North America Llc
- Affected units
- 144
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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