Philips Intera 1.5T MRI Scanner Quadrature Body Coil Seal Adhesive Failure
Philips is recalling Intera 1.5T Explorer/Nova Dual MRI scanners (Model 781108) due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges that could contact patients during scanning and cause skin 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 an FDA Class II recall for a medical device where patient injury has not yet been reported but the hazard presents a clear risk of harm (skin abrasions, lacerations, tissue injury) through a structural failure mechanism (seal adhesive failure). Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Intera 1.5T Explorer/Nova Dual MRI scanner, Model Number 781108. The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that could come into contact with patients during the scanning process.
If the QBC seal becomes loose during scanning, patients may be at risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury. The recall affects 12 units worldwide, including 2 units distributed in the United States.
Healthcare facilities using this equipment should immediately inspect the Quadrature Body Coil seal for signs of failure or loosening. Affected facilities should contact Philips Medical Systems Nederland B.V. for instructions on inspection, repair, or replacement of the device.
The recalled product
- Product
- Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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)
- Model Number (REF): 781108
- UDI-DI: N/A
- All serial numbers.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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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