Philips Ingenia 1.5T MRI System Recalled for Ceiling Speaker Hazard
Philips is recalling Ingenia 1.5T MRI systems because ceiling speakers may fall due to magnetic attraction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II and involves a risk of physical injury from falling objects, but no specific injuries or hospitalizations are reported in the source text, placing it in the High severity category.
Plain-English summary
Philips Medical Systems Nederlands is recalling the Ingenia 1.5T Nuclear Magnetic Resonance Imaging System, Model Number 781341. The recall involves 11,226 units distributed nationwide in the United States.
The recall was 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 pose a risk of injury to patients or staff in the vicinity of the equipment.
Healthcare facilities using these systems should contact Philips Medical Systems Nederlands for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Ingenia 1.5T, Model Number 781341. 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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