Ingenia Ambition S-a MRI System tabletop may not move in manual mode
The Philips Ingenia Ambition S-a MRI system may not fully move its patient tabletop in or out of the bore during manual mode operation, potentially delaying patient evacuation and treatment.
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 risk-of-harm (patient evacuation delay leading to treatment delay) but no reported injuries. Per the severity rubric, recalls involving risk of harm without reported injury fall into the High category.
Plain-English summary
Philips North America LLC is recalling the Ingenia Ambition S-a Magnetic Resonance (MRI) system (model 781359) due to a defect in manual mode operation. The patient tabletop may not completely move in or out of the bore.
When using manual mode, the affected tabletop may fail to move fully, potentially delaying patient evacuation from the MRI bore and, consequently, delaying medical treatment. Approximately 99 units have been distributed worldwide, including throughout the United States and internationally.
Patients and healthcare providers with affected systems should contact Philips to confirm whether their device is affected via the provided serial numbers and to obtain instructions for remediation or other resolution.
The recalled product
- Product
- Ingenia Ambition 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…
- Manufacturer
- Philips North America Llc
- Affected units
- 99
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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