Philips Intera 0.5T MRI Scanner Recall Due to Sharp Coil Seal Edges
Philips has recalled 14 Intera 0.5T MRI scanners due to potential failure of the Quadrature Body Coil seal adhesive, which may 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: FDA Class II recall without reported illnesses or injuries, but involving risk of patient harm from potential sharp edges during a medical procedure. The hazard is theoretical (adhesive 'may fail') rather than confirmed to have caused actual injury.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling 14 units of the Intera 0.5T Standard MRI scanner (Model 781101) due to a potential defect in the Quadrature Body Coil (QBC) seal adhesive.
The adhesive securing the QBC seal may fail during use, creating sharp edges. If the seal becomes loose during the scanning process, these sharp edges may come into contact with patients, potentially causing skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
The affected units have been distributed nationwide in the United States and internationally across numerous countries. All serial numbers of Model 781101 are included in this recall.
Healthcare facilities and patients should contact Philips Medical Systems or the FDA with questions regarding this recall.
The recalled product
- Product
- Intera 0.5T Standard, Model Number: 781101;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- sharp-edges
- laceration
- abrasion
- bruising
- 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): 781101
- UDI-DI: N/A
- All serial numbers.
Distribution
Distributed nationwide across the United States.
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