Philips Ingenia MRI System Recalled Due to Ceiling Speaker Hazard
Philips is recalling Ingenia 1.5T CX MRI systems because ceiling speakers may be pulled by the magnetic field and fall.
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 Ingenia 1.5T CX Nuclear Magnetic Resonance Imaging Systems (Model Number 781261). The recall involves 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 MR 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. Consumers should not use the affected systems until the manufacturer provides guidance.
The recalled product
- Product
- Ingenia 1.5T CX, Model Number 781261. 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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