Philips Intera 1.0T MRI System Quadrature Body Coil Seal Adhesive Failure
Philips is recalling Intera 1.0T Omni/Stellar MRI systems (37 units: 3 in US, 34 internationally) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that can cause skin injuries during patient scanning.
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 injury hazards (skin abrasion, laceration, tissue injury) have been identified and the mechanism of harm is clear, though no reported illnesses or injuries are stated in the source. The source describes a risk-of-harm scenario with direct contact potential, meeting the High severity criterion.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Intera 1.0T Omni/Stellar MRI system, Model Number 781102. The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that can 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. A total of 37 units have been distributed: 3 in the United States (nationwide distribution) and 34 internationally across multiple countries.
Patients or healthcare providers who have one of these devices should contact the manufacturer or their authorized distributor for guidance on corrective measures. All serial numbers are affected under Model Number 781102.
The recalled product
- Product
- Intera 1.0T Omni/Stellar, Model Number: 781102;
- 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): 781102
- 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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