Philips Achieva 3.0T MRI System Recalled Due to Ceiling Speaker Hazard
Philips is recalling 11,226 Achieva 3.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect where components can fall and be pulled by a magnetic field, posing a significant risk of injury or property damage, which aligns with the 'Severe' criteria for significant injury/property-damage reports or structural defects.
Plain-English summary
Philips Medical Systems Nederlands is recalling 11,226 Achieva 3.0T Nuclear Magnetic Resonance Imaging (MRI) systems, Model Number 781177. The recall covers all systems distributed nationwide in the United States.
The recall is being issued because there is a potential for the ceiling speakers to fall from their position and be pulled to the MRI system by the magnetic field. This hazard could result in injury or property damage if the speakers detach and are attracted to the magnet.
Healthcare facilities and consumers with these systems should contact Philips Medical Systems Nederlands for instructions on how to resolve the issue. Do not use the affected systems until the manufacturer provides guidance or a fix.
The recalled product
- Product
- Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System
- Manufacturer
- Philips Medical Systems Nederlands
- Category
- Medical Device — MRI System
- Affected units
- 11,226
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)
- All systems
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 64 recalled by Philips Medical Systems Nederlands 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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