MRI Tabletop May Not Move Properly in Manual Mode
The patient tabletop on affected Philips Ingenia Elition MRI systems may not move completely in or out during manual operation, potentially delaying patient evacuation from the device.
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 device recall involving a mechanical failure that creates a risk-of-harm situation (inability to safely evacuate patients from the device bore), although no injuries or illnesses have been reported.
Plain-English summary
Philips North America LLC has recalled 228 units of the Ingenia Elition X-a Magnetic Resonance (MRI) system. The device is used as a diagnostic imaging system to produce cross-sectional, spectroscopic images and spectra of the head, body, or extremities.
When the MRI system operates in manual mode, the patient tabletop may not completely move in or out of the device. This malfunction could result in a delay in patient evacuation from the scanner bore, which could in turn delay treatment.
The affected model is 781358, distributed worldwide including throughout the United States. The U.S. Food and Drug Administration issued this as a Class II device recall.
The recalled product
- Product
- Ingenia Elition X-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
- 228
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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