Philips Ingenia 3.0T MRI System Recalled for Falling Speaker Hazard
Philips is recalling Ingenia 3.0T 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 agency classified this as a Class II recall, and the hazard involves a physical object falling due to magnetic attraction, which presents a significant risk of injury.
Plain-English summary
Philips Medical Systems Nederlands is recalling the Ingenia 3.0T, Model Number 781377, Nuclear Magnetic Resonance Imaging System. The recall involves 11,226 units 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 pose a risk of injury to patients or staff in the vicinity of the equipment.
Healthcare facilities should contact Philips Medical Systems Nederlands for instructions on how to address this issue. The agency has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Ingenia 3.0T, Model Number 781377. 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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