Agency classClass IIOur severity:High FDA (Devices)·Z-2414-2021·Announced 2021-09-15

MRI Tabletop Movement Malfunction in Manual Mode Affects Philips Ingenia Systems

Philips Ingenia 1.5T CX-a MRI systems may have a tabletop that fails to fully move in or out during manual 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: This is an FDA Class II recall involving a risk-of-harm scenario where a mechanical malfunction could delay patient evacuation and treatment. No illnesses, injuries, or deaths have been reported. The recall meets the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Philips North America LLC is recalling certain Ingenia 1.5T CX-a Magnetic Resonance (MRI) systems, models 781261 and 781262. These systems are diagnostic medical devices used to produce detailed images of the head, body, and extremities.

In manual mode, the patient tabletop may not completely move in or out of the MRI bore. This malfunction could delay patient evacuation and result in delayed treatment.

The affected devices were distributed worldwide, including throughout the United States. A total of 12 units of model 781261 and 137 units of model 781262 are included in this recall.

This is a Class II recall issued by the FDA.

The recalled product

Product: Ingenia 1.5T CX-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 Models…
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging / MRI System
Hazard: mechanical-failure
evacuation-delay
treatment-delay

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.

See all 12 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · mechanical failure