Philips MRI coil seal adhesive may fail, creating sharp edges and injury risk
A Philips MRI coil component's adhesive may fail and create sharp edges that could injure patients during scanning. The defect affects 286 units worldwide.
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 illnesses or injuries. The hazard is theoretical—potential skin and tissue injury from sharp edges—placing this in the High severity tier for risk-of-harm products without reported harm.
Plain-English summary
Philips North America is recalling certain models of the SmartPath to dStream for XR and 3.0T magnetic resonance imaging (MRI) system components. Specifically, the Quadrature Body Coil (QBC) seal adhesive may fail, causing sharp edges that could contact patients during a scanning procedure.
If the QBC seal becomes loose during the scanning process, sharp edges created by the failed adhesive may cause skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury to patients. The recall involves 286 units: 21 distributed in the United States and 265 distributed internationally.
Patients and healthcare facilities using the affected MRI equipment should contact Philips North America to arrange inspection, repair, or replacement of the QBC component to prevent patient injury.
The recalled product
- Product
- SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
- 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 (4)
- a. Model No. 781270
- UDI-DI 00884838095083. b. Model No. 782113
- UDI-DI 00884838098909. c. Model No. 782129
- UDI-DI 00884838105805. 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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