Philips MRI Coil Seal Adhesive May Fail and Create Sharp Patient Contact Surfaces
Philips has recalled certain SmartPath to dStream MRI coil components because the seal adhesive may fail, creating sharp edges that could contact patients during scanning and cause skin and tissue injuries.
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: This is a risk-of-harm medical device with a specific identified hazard (seal adhesive failure creating sharp edges capable of patient contact) where injury has not yet been reported in the source text. The potential injuries listed (lacerations, tissue injury) could be serious if they occur, but no actual incidents or hospitalizations are documented, placing this in the High category per the rubric.
Plain-English summary
Philips North America is recalling SmartPath to dStream for 1.5T MRI coil components (Model Numbers 781260 and 782112) because the Quadrature Body Coil (QBC) seal adhesive may fail. If the seal becomes loose during the scanning process, sharp edges on the coil may come into contact with patients.
This recall affects 37 units in the United States and 735 units outside the United States. The identified hazards include potential skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury to patients.
Healthcare facilities using affected equipment should contact Philips North America for inspection and repair instructions. Patients scheduled for MRI scans using these coils should discuss any concerns about equipment safety with their medical provider before the procedure.
The recalled product
- Product
- SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
- 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. 781260
- UDI-DI 00884838095076. b. Model No. 782112
- UDI-DI 00884838098886. 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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