MRI Magnetic Resonance System Tabletop May Fail to Move in Manual Mode
Philips Ingenia Elition S-a MRI systems may have tabletop movement failure in manual mode, potentially delaying patient evacuation from the scanner bore and treatment. This affects 64 units distributed 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 medical device with no reported injuries or illnesses. The hazard represents a risk of treatment delay rather than confirmed harm, fitting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Philips North America LLC is recalling 64 units of the Ingenia Elition S-a Magnetic Resonance (MR) system, a diagnostic medical device used to produce detailed cross-sectional and spectroscopic images of the body.
The recall addresses a functionality hazard: in manual mode, the patient tabletop may not completely move in or out of the scanner bore. This malfunction could result in a delay in patient evacuation from the bore, which in turn could delay medical treatment.
The affected devices have been distributed worldwide, including throughout the United States and to over 70 countries internationally. Healthcare facilities with affected serial numbers should review the detailed identifier list and determine if their equipment is included.
Facilities should contact Philips for instructions on device inspection, repair, or mitigation measures.
The recalled product
- Product
- Ingenia Elition 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 Models…
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Systems
- Affected units
- 64
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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