Philips Intera 3.0T Quasar Dual MRI Scanner Coil Seal Adhesive Failure
Philips is recalling the Intera 3.0T Quasar Dual MRI scanner (Model 781150) 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: FDA Class II medical device recall where the failure of the QBC seal adhesive creates a risk of patient harm (skin abrasions, lacerations, tissue injury). The source text does not report any illnesses or injuries that have actually occurred, making this a risk-of-harm scenario without reported adverse events, which per the rubric constitutes a High severity rating.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Intera 3.0T Quasar Dual MRI scanner, Model Number 781150. The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients during the scanning process.
If the QBC seal becomes loose during scanning, patients are at risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
A total of 12 units have been distributed: 5 units in the United States (nationwide distribution) and 7 units internationally across multiple countries including Canada, the United Kingdom, Germany, France, Japan, China, Australia, and others.
Facilities using this scanner should contact Philips for information about inspection and remediation of the affected units.
The recalled product
- Product
- Intera 3.0T Quasar Dual, Model Number: 781150;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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): 781150
- 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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