Philips Intera 1.0T MRI System Recalled for Ceiling Speaker Hazard
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
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 is classified as FDA Class II and involves a structural defect (falling speakers) that poses a significant injury risk, meeting the criteria for a Severe rating.
Plain-English summary
Philips Medical Systems Nederlands is recalling Intera 1.0T Power/Pulsar MRI systems, Model Number 781103. 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 to patients or staff.
Healthcare facilities should contact Philips Medical Systems Nederlands for instructions on how to address this issue. The agency has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Intera 1.0T Power/Pulsar, Model Number 781103. 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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