Philips Achieva 1.5T MRI Systems Recalled for Gradient Coil Fire Risk
Philips is recalling Achieva 1.5T MRI systems because the gradient coil component could fail and produce smoke or fire. The recall affects 2 units 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: FDA Class II recall for potential gradient coil failure that could produce fire and smoke, with no incidents reported. This meets the rubric for High severity as a risk-of-harm product without reported injury.
Plain-English summary
Philips North America LLC is recalling the Achieva 1.5T Initial System, a magnetic resonance imaging (MRI) machine used in medical facilities. The recall involves 2 units.
A potential failure in the gradient coil—a key component of the MRI system—could result in smoke and/or fire. The affected units have serial numbers 21605 and 21695.
The units have been distributed nationwide in the United States and to numerous countries worldwide, including Canada, United Kingdom, Germany, France, Japan, and Australia.
The recalled product
- Product
- Achieva 1.5T Initial System
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Affected units
- 2
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 (4)
- Product No. 781178
- UDI-DI: N/A
- Serial No. 21605
- 21695.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Philips North America Llc 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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