MRI Scanner Quadrature Coil Seal Failure Poses Patient Contact Risk
Philips is recalling the Intera 1.5T Achieva Nova-Dual MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive. If the seal fails, sharp edges may contact patients, risking skin injuries.
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 FDA Class II recall involves potential patient contact with sharp edges that could cause injury (abrasions, lacerations, tissue damage). However, no actual injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the criterion for High severity.
Plain-English summary
Philips North America is recalling the Intera 1.5T Achieva Nova-Dual MRI scanner (Model 781173), a medical imaging device used to obtain detailed internal body images. The Quadrature Body Coil (QBC) seal adhesive may fail during normal scanning operations.
When the QBC seal fails, sharp edges may form that could come into contact with patients undergoing MRI scans. This poses a risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
Four units of the affected model have been distributed within the US, and 17 units have been distributed outside the US.
The recalled product
- Product
- Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
- Manufacturer
- Philips North America
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. 781173
- 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.
See all 12 products in this recall →Related recalls
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