Agency classClass IIOur severity:High FDA (Devices)·Z-0948-2024·Announced 2024-02-07

Philips Achieva 3.0T MRI Coil Seal Adhesive May Fail, Risking Patient Injury

The Quadrature Body Coil seal adhesive in Philips Achieva 3.0T MRI scanners may fail, creating sharp edges that can injure patients. All units with model numbers 781277, 781177, 781278, 781344, and 781345 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: Class II recall of a medical device posing injury risk through sharp edges that could cause skin abrasions, lacerations, and tissue injury. No incidents have been reported, placing this in the High category per the severity rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America is recalling the Achieva 3.0T magnetic resonance imaging (MRI) scanner, models 781277, 781177, 781278, 781344, and 781345. The device contains a Quadrature Body Coil (QBC) with a seal adhesive that may fail under normal operating conditions.

If the QBC seal fails during the scanning process, sharp edges may develop and make contact with patients. This can result in skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.

Approximately 75 units were distributed in the United States, and 442 units were distributed outside the US. Healthcare facilities operating affected equipment should discontinue use and contact Philips North America for repair or replacement instructions. Patients who may have used the equipment should contact their healthcare provider if they develop any cuts, abrasions, or other injuries.

The recalled product

Product: Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
Manufacturer: Philips North America
Category: Medical Device — MRI Scanner
Hazard: seal-failure
sharp-edges
skin-abrasion
laceration
tissue-injury
hair-entanglement

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 (6)

a. Model No. 781277
UDI-DI N/A. b. Model No. 781177
UDI-DI N/A. c. Model No. 781278
UDI-DI 00884838004139. d. Model No. 781344
UDI-DI N/A. e. Model No. 781345
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 →

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Same hazard · seal failure