Philips Achieva MRI System Recalled for Falling Ceiling Speaker Hazard
Philips is recalling Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device where a component could fall and be pulled by a magnetic field, posing a significant risk of injury or property damage, which aligns with the 'Severe' criteria for structural defects or significant injury reports.
Plain-English summary
Philips Medical Systems Nederlands is recalling the Achieva 1.5T Conversion, Model Number 781283, Nuclear Magnetic Resonance Imaging System. The recall involves 11,226 units distributed nationwide in the United States.
The recall is issued because there is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. This hazard could result in injury or property damage.
Healthcare facilities using these systems should contact Philips Medical Systems Nederlands for further instructions on how to address the issue.
The recalled product
- Product
- Achieva 1.5T Conversion, Model Number 781283. 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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