Agency classClass IIOur severity:High FDA (Devices)·Z-3199-2024·Announced 2024-10-02

MRI Diagnostic Device Recalled for Loose Assembly Screws Blocking Equipment

Philips Ingenia Elition S MRI machines (10 units) are recalled because assembly screws may come loose and interfere with the horizontal tabletop, potentially delaying diagnosis and causing patient anxiety.

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 a Class II medical device recall with a mechanical defect posing risk to proper patient care and diagnosis. No injuries or illnesses have been reported, but the potential for diagnostic delay and patient discomfort is documented in the source material, meeting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling 10 Ingenia Elition S MRI diagnostic devices due to a defect in the Integrated Radio Frequency (IRF) Carrier assembly. The assembly screws may come loose and protrude beyond the surface, where they could interfere with other moving parts and potentially block the horizontal tabletop.

The affected units are identified by serial numbers: 26020, 26023, 26026, 26034, 46240, 46270, 46310, 46315, 46324, and 46352. These devices have worldwide distribution, including across the United States and over 50 additional countries.

If the tabletop becomes blocked due to protruding screws, it may delay patient diagnosis and leave patients in the MRI bore longer than anticipated, which may cause anxiety. Healthcare facilities operating these specific serial-numbered units should contact Philips for inspection and repair guidance.

The recalled product

Product: Ingenia Elition 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) 782150 2) 782106
Manufacturer: Philips North America Llc
Category: Medical Device — MRI / Diagnostic Imaging
Hazard: loose-fasteners
equipment-malfunction
diagnostic-delay
Affected units: 10

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: 782150 (01)00884838098329(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 · loose fasteners