Philips Intera 1.5T MRI Quadrature Body Coil seal adhesive failure
Philips is recalling Intera 1.5T MRI systems due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and contact patient skin during scanning.
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: This is an FDA Class II recall involving a medical device with risk of injury to patients (abrasions, lacerations, tissue injury). The source text does not report any illnesses or injuries to date; the hazard is based on potential injury from sharp edges if seal failure occurs during use. Per the rubric, Class II with potential for injury (but no reported cases) aligns with a High severity rating.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Intera 1.5T MRI machines, Model Numbers 781195 and 781295 (37 units in the US, 339 internationally). The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges.
If the QBC seal becomes loose during the scanning process, sharp edges may come into contact with patients. Potential injuries include skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
Patients and healthcare facilities using affected models should contact Philips or their representative for guidance on this issue.
The recalled product
- Product
- Intera 1.5T, Model Numbers: 781195 and 781295;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — MRI Equipment
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)
- Model Numbers (REF): 781195
- 781295
- UDI-DIs: 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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