Philips Intera 0.5T MRI System Recalled for Falling Speaker Hazard
Philips is recalling 11,226 Intera 0.5T 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 heavy objects) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Philips Medical Systems Nederlands is recalling 11,226 Intera 0.5T Standard Nuclear Magnetic Resonance Imaging (MRI) systems, Model Number 781101. The recall covers systems 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 to patients or staff if the speakers detach and strike individuals in the room.
Healthcare facilities should contact Philips Medical Systems Nederlands for instructions on how to address the issue. Consumers and patients should be aware that this recall affects specific MRI systems and should follow guidance from their healthcare provider regarding the safety of their imaging appointments.
The recalled product
- Product
- Intera 0.5T Standard, Model Number 781101. 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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