Philips Intera 1.5T MRI System Recalled for Ceiling Speaker Hazard
Philips is recalling Intera 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 falling components could cause significant injury or property damage, meeting the criteria for a Severe rating.
Plain-English summary
Philips Medical Systems Nederlands is recalling 11,226 Intera 1.5T Nuclear Magnetic Resonance Imaging (MRI) systems, Model Number 781195. The recall covers all 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 presents a risk of injury or property damage if the speakers detach and are attracted to the magnet.
Healthcare facilities using these MRI systems should contact Philips Medical Systems Nederlands for further instructions on how to address the issue. Consumers and patients should be aware that this recall involves the facility's equipment rather than a direct consumer product in their homes.
The recalled product
- Product
- Intera 1.5T, Model Number 781195. 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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