Philips Achieva 1.5T MRI system recalled for defective coil seal
Philips is recalling the Achieva 1.5T Initial MRI system due to a defective Quadrature Body Coil seal. The adhesive may fail and create sharp edges that could cut or abrade 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 device recall for a structural defect in medical imaging equipment. The defective seal adhesive may create sharp edges that could contact patients, risking skin injuries. No illnesses or injuries have been reported; the hazard is conditional on equipment failure.
Plain-English summary
Philips North America is recalling the Achieva 1.5T Initial magnetic resonance imaging (MRI) system, Model 781178. This system is used in medical facilities to perform diagnostic MRI scans. The recall affects 23 units distributed in the United States and 51 units distributed overseas.
The Quadrature Body Coil (QBC) seal adhesive in these systems may fail, creating sharp edges. If the QBC seal becomes loose during a patient scanning procedure, the sharp edges may come into contact with patients, posing a risk of skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
Philips North America is notifying facilities that operate this equipment. Healthcare facilities and imaging centers should contact Philips North America for instructions on system inspection, repair, or mitigation options.
The recalled product
- Product
- Achieva 1.5T Initial system. Model (REF) Numbers 781178.
- 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 (1)
- Model No. 781346 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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