MRI Machine Coil Seal Adhesive May Create Sharp Edges
The Intera Achieva 1.5T Pulsar MRI machine's Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. All units of this model are affected.
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 a risk-of-harm product where injury has not yet been reported. The adhesive failure creates a clear hazard of skin and tissue injury through contact with sharp edges, meeting the criteria for a High severity rating despite the absence of documented incidents.
Plain-English summary
Philips North America is recalling the Intera Achieva 1.5T Pulsar MRI machine (Model 781171) due to a potential defect in the Quadrature Body Coil seal adhesive.
The seal adhesive may fail during the scanning process, creating sharp edges on the coil. If these sharp edges come into contact with patients during scanning, they pose a risk of injury including skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
All units of this model are affected. Healthcare facilities should take appropriate precautions. For guidance on device inspection or servicing, contact Philips North America or the FDA.
The recalled product
- Product
- Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Machine
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 (2)
- Model No. 781171
- UDI-DI N/A. All units affected
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Philips North America 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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- Severe
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