Philips MRI Systems Recalled Due to Ceiling Speaker Fall Risk
Philips is recalling Intera 1.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
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 in a clinical setting) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems Nederlands is recalling Intera 1.0T Omni/Stellar Nuclear Magnetic Resonance Imaging Systems, Model Number 781102. 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 MR system by the magnetic field. This hazard could result in injury to patients or staff or damage to the equipment.
Healthcare facilities should contact Philips Medical Systems Nederlands for instructions on how to address the issue. Consumers and patients should not use the affected systems until the issue is resolved.
The recalled product
- Product
- Intera 1.0T Omni/Stellar, Model Number 781102. 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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