Agency classClass IIOur severity:High FDA (Devices)·Z-0949-2024·Announced 2024-02-07

Philips Achieva XR MRI Coil Seal Adhesive Failure Risk

Philips Achieva XR MRI body coil seal adhesive may fail and create sharp edges that could injure patients. Affected units are being recalled.

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: FDA Class II recall with no reported injuries, but describing potential harm to patients (lacerations, tissue injury) from a mechanical defect where injury has not yet occurred, meeting the Score 3 (High) criterion for risk-of-harm products without reported illness.

Plain-English summary

Philips North America is recalling all units of the Achieva XR (Models 781153 and 781253) due to a defect in the Quadrature Body Coil (QBC) seal adhesive. Affected units total 23 in the US and 20 outside the US.

The QBC seal adhesive may fail, creating sharp edges that could come into contact with patients. If the seal becomes loose during the scanning process, patients may be at risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.

If you have one of the affected models, contact Philips North America immediately for recall instructions. Do not use the equipment until you receive further guidance from the company.

The recalled product

Product: Achieva XR. Model (REF) Numbers 781153, 781253.
Manufacturer: Philips North America
Category: Medical Device — Imaging Equipment / Scanner Coil
Hazard: seal-failure
sharp-edges
laceration
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. 781153
UDI-DI N/A. b. Model No. 781253
UDI-DI N/A. 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 →

Same manufacturer · Philips North America

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Same hazard · seal failure