Philips Intera MRI Scanner Coil Seal May Create Sharp Edges
Philips Intera 1.5T MRI scanners may develop sharp edges from a failing quadrature coil seal adhesive, risking patient skin injuries during scanning procedures. The recall affects 23 units distributed in the US and internationally.
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: FDA Class II medical device recall with documented potential for patient injuries (skin abrasions, lacerations, tissue injury) from a specific hardware failure mode, but no reported injuries to date. Meets the risk-of-harm criterion for High severity without hospitalization reports.
Plain-English summary
Philips Medical Systems has recalled Intera 1.5T R11 MRI scanners (Model 781170) due to a potential failure in the Quadrature Body Coil (QBC) seal adhesive.
The adhesive that seals the QBC may deteriorate, creating sharp edges that could come into contact with patients during MRI scanning procedures. This poses a risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
The recall affects 23 units total: 10 in the United States and 13 internationally. These units were distributed nationwide in the US and to over 80 countries globally. All serial numbers of affected model 781170 systems are included in this recall.
Healthcare facilities operating affected equipment should contact Philips Medical Systems for repair or replacement instructions to prevent potential patient injury.
The recalled product
- Product
- Intera 1.5T R11, Model Number: 781170;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- sharp-edges
- skin-abrasion
- laceration
- 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): 781170
- UDI-DI: N/A
- All serial numbers.
Distribution
Distributed nationwide across the United States.
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