Philips Ingenia Ambition X MRI System Tabletop May Fail to Retract
Philips Ingenia Ambition X MRI systems may have tabletops that fail to move completely in manual mode, potentially delaying patient evacuation from the scanner and treatment. The issue affects 147 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: This is an FDA Class II medical device recall with no reported injuries or illnesses. The hazard—a mechanical failure that could delay patient evacuation and treatment—qualifies as a risk-of-harm product without documented adverse events, warranting a Score of 3 per the rubric.
Plain-English summary
Philips North America LLC is recalling certain Ingenia Ambition X Magnetic Resonance (MRI) systems due to a tabletop movement issue in manual mode. The affected units (Model 781356) consist of 147 systems distributed worldwide, including throughout the United States.
In manual mode operation, the 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 and subsequently delay medical treatment.
This recall affects healthcare facilities and imaging centers operating the affected Ingenia Ambition X systems. The FDA classifies this as a Class II recall. Healthcare providers who operate affected units should contact Philips North America LLC for service information and corrective measures.
The recalled product
- Product
- Ingenia Ambition X- 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
- Affected units
- 147
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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