Agency classClass IIOur severity:High FDA (Devices)·Z-0950-2024·Announced 2024-02-07

Philips Ingenia MRI Scanner Body Coil Seal Adhesive May Fail

Philips is recalling Ingenia 1.5T CX MRI scanners because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. Model numbers 781262 and 781261 are affected.

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 describes a medical device failure mode that creates sharp edges posing clear risk of patient injury including lacerations, tissue damage, and hair entanglement. It fits the High severity category as a risk-of-harm product.

Plain-English summary

Philips North America has issued a recall of the Ingenia 1.5T CX Magnetic Resonance Imaging (MRI) scanner, Model Numbers 781262 and 781261. These devices are medical imaging systems used in healthcare settings for diagnostic scans.

The recall was issued because the Quadrature Body Coil (QBC) seal adhesive may fail during use. If the seal becomes loose during scanning, it can create sharp edges that may contact patients, risking skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.

The recall affects all units of the stated models, with 146 units distributed outside the United States. The FDA has classified this as a Class II recall.

Healthcare facilities with these systems should consult the official FDA recall listing (Z-0950-2024) for further information.

The recalled product

Product: Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
Manufacturer: Philips North America
Category: Medical Device — Magnetic Resonance Imaging System
Hazard: sharp-edges
laceration
hair-entanglement
tissue-injury

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 (3)

a. Model No. 781262
UDI-DI 00884838068445. b. Model No. 781261
UDI-DI 00884838068438. All units affected

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Philips North America 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 →

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Same hazard · sharp edges