Agency classClass IIOur severity:High FDA (Devices)·Z-3197-2024·Announced 2024-10-02

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.

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 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
Category: Medical Device — Diagnostic Imaging / MRI
Hazard: mechanical-failure
device-obstruction
diagnostic-delay
Affected units: 64

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.

Part of a larger recall action

This product is one of 13 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.

See all 13 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · mechanical failure