Philips Intera CV MRI System Seal Adhesive May Fail, Creating Sharp Edges
The Quadrature Body Coil seal adhesive on Philips Intera CV MRI systems may fail and create sharp edges that could contact patients during scanning. Potential injuries include skin abrasions, bruises, lacerations, hair loss, and tissue damage.
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 device recall. The source describes potential patient harm through skin abrasions, lacerations, tissue injury, and hair entanglement if the QBC seal adhesive fails, but no illnesses or injuries have been reported. Per the rubric, when no illnesses are reported and the hazard is theoretical, the score is at most 3 (High).
Plain-English summary
Philips MEDICAL SYSTEMS is recalling Intera CV MRI systems (Model 781107) due to a defect in the Quadrature Body Coil (QBC) seal adhesive that affects all units of this model.
The seal adhesive may fail, creating sharp edges that could contact patients during the scanning process. Patients exposed to a loose or failed QBC seal may experience skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
Six units are affected by this recall: four distributed in the United States with nationwide distribution, and two distributed internationally to over 90 countries.
Healthcare providers should contact the manufacturer for instructions on inspection, repair, or replacement of the affected component. As of this notice, no patient injuries have been reported.
The recalled product
- Product
- Intera CV, Model Number: 781107;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- seal-failure
- sharp-edges
- skin-injury
- 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): 781107
- UDI-DI: N/A
- All serial numbers.
Distribution
Distributed nationwide across the United States.
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