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
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.
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