MRI Device Ingenia Ambition S Screws May Loosen and Block Tabletop
Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.
What this means for you
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 FDA Class II recall involves a mechanical defect that could impair critical device function and delay patient diagnosis. No hospitalizations or injuries have been reported, which meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling the Ingenia Ambition S, a diagnostic medical imaging device used to obtain cross-sectional and spectroscopic images of the head, body, and extremities. The recall affects 64 units distributed worldwide, including throughout the United States and numerous international locations.
Screws in the Integrated Radio Frequency (IRF) Carrier assembly may come loose and protrude beyond the device's surface. When this occurs, the protruding screws can interfere with the device's moving parts and potentially block the horizontal patient tabletop.
A blocked tabletop could prevent normal device operation, resulting in delayed diagnosis. Additionally, patients positioned inside the MRI bore may experience prolonged anxiety if they remain in the device longer than anticipated due to the mechanical obstruction.
This is a Class II recall issued by the FDA. Facilities operating Ingenia Ambition S devices with the affected serial numbers should contact Philips for guidance on repair or replacement options.
The recalled product
- Product
- Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782108 2) 781359 3) 782133
- Manufacturer
- Philips North America Llc
- Hazard
- mechanical-failure
- device-obstruction
- diagnostic-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model UDI-DI: 782108 (01)00884838098343(21)
Distribution
Distributed nationwide across the United States.
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