Philips Intera 1.5T MRI Scanner Body Coil Seal Failure Recall
Philips is recalling 103 Intera 1.5T MRI scanners worldwide because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, bruises, lacerations, hair loss, or tissue injury to patients.
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 for a medical device with a structural defect (seal adhesive failure) that poses a direct risk of harm to patients, including potential lacerations and tissue injury. The source text does not report any actual illnesses or injuries, making this a risk-of-harm situation rather than a reported-harm situation, which aligns with the High severity threshold.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Intera 1.5T Master/Nova MRI scanner (Model Number 781106) because the Quadrature Body Coil (QBC) seal adhesive may fail during use.
The defect creates sharp edges on the coil. If the QBC seal becomes loose during the scanning process, these sharp edges may come into contact with patients, posing a risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
A total of 103 units have been affected: 37 units distributed in the United States with nationwide distribution, and 66 units distributed internationally across multiple countries and regions. All serial numbers of Model Number 781106 are included in this recall.
Philips Medical Systems Nederland B.V. is the recalling firm. Customers with affected equipment should contact the manufacturer for guidance on inspection, repair, or replacement options.
The recalled product
- Product
- Intera 1.5T Master/Nova, Model Number: 781106;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — MRI Scanner
- Hazard
- sharp-edges
- laceration
- tissue-injury
- seal-failure
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): 781106
- UDI-DI: N/A
- All serial numbers.
Distribution
Distributed nationwide across the United States.
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