Achieva 1.5T MRI Coil Seal Adhesive May Fail Creating Sharp Edges
Philips Achieva 1.5T MRI scanner components may experience coil seal adhesive failure, creating sharp edges that could injure patients. Affected devices have been distributed worldwide.
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 of a medical imaging device where seal adhesive failure can create sharp edges with direct patient contact risk during scanning procedures. Although no injuries have been reported, the potential for multiple types of injury (abrasions, lacerations, tissue damage) meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips is recalling Achieva 1.5T Conversion MRI scanner components, specifically the Quadrature Body Coil (QBC) assembly in Models 781346 and 781283. These are magnetic resonance imaging devices used in medical facilities.
The QBC seal adhesive may fail, creating sharp edges on the component. If the seal becomes loose during the scanning process, these sharp edges could come into contact with patients.
Potential risks to patients from contact with sharp edges include skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury. The affected devices have been distributed both within the United States and internationally.
Healthcare providers using Philips Achieva 1.5T MRI scanners should contact Philips North America for further guidance regarding affected units and any necessary corrective actions or inspection procedures.
The recalled product
- Product
- Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Scanner
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)
- a. Model No. 781346
- UDI-DI 00884838068469. b. Model No. 781283
- UDI-DI 00884838009806. 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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