Philips Enterprise 1.5T MRI Equipment Quadrature Body Coil Seal
Philips is recalling Enterprise 1.5T MRI scanners (Model 781145) 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: This is an FDA Class II recall involving a medical device with a risk-of-harm hazard (sharp edges, potential for skin abrasions, lacerations, and tissue injury). The source text does not report any confirmed illnesses or injuries to date, so the score does not exceed 3 per the rubric.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Enterprise 1.5T magnetic resonance imaging (MRI) equipment, Model Number 781145, due to a defect in the Quadrature Body Coil (QBC) seal adhesive. The adhesive may fail during use, creating sharp edges that pose a risk of contact with patients.
If the QBC seal becomes loose during a scanning procedure, patients may experience skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury. A total of 34 units have been distributed: 32 in the United States (nationwide) and 2 internationally.
Healthcare facilities that operate this equipment should inspect the QBC seal for signs of looseness or damage. Customers should contact Philips Medical Systems Nederland B.V. for further guidance on inspection, repair, or replacement of affected devices. All serial numbers of Model 781145 are included in this recall.
The recalled product
- Product
- Enterprise 1.5T, Model Number: 781145;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — MRI Equipment
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): 781145
- 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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