Philips Intera 1.5T MRI machines recalled for loose body coil seal adhesive
Philips is recalling certain Intera 1.5T MRI machines because the body coil seal adhesive may 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 an FDA Class II recall with no reported injuries or hospitalizations. The hazard poses a real risk of harm (lacerations, tissue injury, entanglement) through physical contact with sharp edges, but the source text does not report any actual patient injuries. Per the severity rubric, recalls with risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Intera 1.5T MRI machines, Model Numbers 781195 and 781295, distributed nationwide in the United States and to 83 additional countries. A total of 376 units have been identified (37 in the US and 339 internationally).
The Quadrature Body Coil (QBC) seal adhesive may fail during use, which could create sharp edges. If the coil seal becomes loose during the scanning process, patients may come into contact with these sharp edges. Potential injuries include skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
This recall affects all units with Model Numbers 781195 and 781295, regardless of serial number. Patients or healthcare providers who operate these machines should contact Philips Medical Systems Nederland B.V. for instructions on how to proceed.
The recalled product
- Product
- Intera 1.5T, Model Numbers: 781195 and 781295;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — MRI Equipment
- Hazard
- sharp-edge
- lacerations
- 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 (4)
- Model Numbers (REF): 781195
- 781295
- UDI-DIs: N/A
- All serial numbers.
Distribution
Distributed nationwide across the United States.
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