Philips Intera 1.5T MRI Scanner QBC Seal Adhesive Failure Risk
Philips is recalling the Intera 1.5T Power/Pulsar MRI scanner because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The source is FDA Class II. The hazard involves potential for injury (skin abrasions, bruises, lacerations, tissue injury) from a medical device failure, and the source text does not report any illnesses or injuries yet. This meets the rubric criterion for High: "risk-of-harm products where injury has not yet been reported."
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Intera 1.5T Power/Pulsar MRI scanner (Model Number 781105) due to a potential failure of the Quadrature Body Coil (QBC) seal adhesive. The adhesive failure may create sharp edges that could come in contact with patients during the scanning process.
If the QBC seal becomes loose during scanning, patients may be at risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury. The recall affects 121 units worldwide, including 51 units distributed in the United States and 70 units distributed internationally across multiple countries.
Facilities using the Intera 1.5T Power/Pulsar with Model Number 781105 should contact Philips Medical Systems for further instructions regarding this recall.
The recalled product
- Product
- Intera 1.5T Power/Pulsar, Model Number: 781105;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — MRI Scanner
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): 781105
- UDI-DI: N/A
- All serial numbers.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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