Agency classClass IIOur severity:High FDA (Devices)·Z-2411-2021·Announced 2021-09-15

MRI diagnostic device tabletop may not move completely in manual mode

Philips Ingenia 1.5T MRI systems may have a mechanical defect where the tabletop fails to move fully in and 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 mechanical defect in a diagnostic device that poses a risk of patient evacuation delay from the MRI bore. No injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High classification.

Plain-English summary

Philips North America LLC is recalling certain Ingenia 1.5T magnetic resonance (MRI) diagnostic imaging systems due to a potential malfunction of the tabletop movement mechanism in manual mode.

The affected systems (Models 781341 and 781396) may fail to move the tabletop completely in or out when operating in manual mode. This could result in delays in patient evacuation from the MRI bore and delays in treatment delivery.

The systems have been distributed worldwide, including throughout the United States. Affected units are identified by specific serial numbers and unique device identifiers (UDI) listed in the FDA recall database.

Patients and healthcare facilities using these systems should contact Philips for guidance on the malfunction, available repairs, or workarounds. No injuries have been reported to the FDA at this time.

The recalled product

Product: Ingenia 1.5T- 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 Equipment
Hazard: device-malfunction
evacuation-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 · device malfunction