The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3200-2024·Announced 2024-10-02

MRI Scanner Loose Screws May Block Tabletop and Delay Diagnosis

The Ingenia Elition X MRI device may have loose screws that interfere with the horizontal tabletop, potentially delaying patient diagnosis and causing anxiety during extended bore exposure.

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 recall involving a medical imaging device with a mechanical defect that could delay patient diagnosis and cause patient anxiety. Although no injuries or illnesses have been reported, the defect represents a risk of harm in a medical device, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Philips North America LLC is recalling 33 Ingenia Elition X MRI (magnetic resonance imaging) devices. The recall is due to a mechanical defect in the Integrated Radio Frequency (IRF) Carrier assembly.

The IRF Carrier assembly screws may become loose and protrude beyond the device surface. This can cause the screws to interfere with other moving parts within the scanner, potentially blocking the horizontal patient tabletop. When the tabletop is blocked, scanning procedures may be delayed and patients already positioned on the tabletop may remain inside the scanner bore longer than anticipated, potentially causing patient anxiety.

The affected units have been distributed worldwide, including throughout the United States and more than 50 countries. Healthcare facilities with one of the recalled devices should contact Philips for inspection and corrective action instructions. This is a Class II recall. No injuries or illnesses related to this issue have been reported.

The recalled product

Product
Ingenia Elition X- 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) 782151; 2) 782119; 3) 781358; 4) 782107; 5)…
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
33

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 (4)

  • Model UDI-DI: 782151 N/A
  • 782119 (01)00884838104129(21)
  • 781358 (01)00884838088115(21)
  • 782107 (01)00884838098336(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 →

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