The Recall Desk
HighFDA (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.

What this means for you

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.

Related recalls

Same category