MRI Scanner Body Coil Seal Adhesive Failure Creates Risk of Sharp Edges
Philips Intera 1.5T MRI scanners may have defective quadrature body coil seals. The adhesive can fail and create sharp edges that could injure patients 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 a Class II FDA recall for a risk-of-harm medical device with potential for patient injury (lacerations, tissue damage, hair entanglement) but with no reported injuries to date, meeting the rubric criterion for High severity.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Intera 1.5T Explorer/Nova Dual MRI scanners (Model 781108) due to a potential defect in the Quadrature Body Coil (QBC) seal adhesive. The adhesive may fail during the scanning process, creating sharp edges that could come into contact with patients.
If the QBC seal becomes loose, patients may experience skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
The recall affects 12 units globally: 2 in the United States with nationwide distribution, and 10 internationally across numerous countries. Healthcare facilities operating affected units should contact the manufacturer for guidance regarding device inspection, repair, or status.
The recalled product
- Product
- Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- sharp-edges
- laceration
- tissue-injury
- hair-entanglement
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.
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