Philips Multiva MRI System Recalled for Ceiling Speaker Hazard
Philips is recalling Multiva 1.5T MRI systems because ceiling speakers may fall due to magnetic attraction.
What this means for you
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: The recall involves a risk-of-harm product (falling objects due to magnetic attraction) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness or injury.
Plain-English summary
Philips Medical Systems Nederlands is recalling the Multiva 1.5T 16 R5 (ZBO) Nuclear Magnetic Resonance Imaging System, Model Number 781073. The recall covers 11,226 units distributed nationwide in the United States.
The recall is 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 strike individuals or equipment.
Healthcare facilities should contact Philips Medical Systems Nederlands for instructions on how to address this issue. The source text does not specify a deadline or immediate shutdown requirement, but facilities should follow the manufacturer's guidance to mitigate the risk.
The recalled product
- Product
- Multiva 1.5T 16 R5 (ZBO), Model Number 781073. 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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