Philips Enterprise 1.5T MRI System Recalled for Falling Speaker Hazard
Philips is recalling Enterprise 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
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 involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems Nederlands is recalling the Enterprise 1.5T Nuclear Magnetic Resonance Imaging System, Model Number 781145. 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 if the speakers detach and move toward the imaging area.
Healthcare facilities should contact Philips Medical Systems Nederlands for instructions on how to address the issue with the ceiling speakers. Consumers and patients should not use the affected MRI systems until the issue has been resolved by the manufacturer.
The recalled product
- Product
- Enterprise 1.5T, Model Number 781145. 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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