Philips Ingenia 3.0T MRI Systems Recalled for Ceiling Speaker Hazard
Philips is recalling 11,226 Ingenia 3.0T 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 (falling objects due to magnetic attraction) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems Nederlands is recalling 11,226 Ingenia 3.0T Nuclear Magnetic Resonance Imaging (MRI) systems, Model Number 781342. The recall covers all systems distributed nationwide in the United States.
The recall is being 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 to patients or staff in the vicinity of the equipment.
Healthcare facilities should contact Philips Medical Systems Nederlands for instructions on how to address this issue. Consumers and patients should not use the affected equipment until the manufacturer provides guidance on corrective actions.
The recalled product
- Product
- Ingenia 3.0T, Model Number 781342. 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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