Philips Intera 1.5T MRI Systems Recalled for Falling Speaker Hazard
Philips is recalling 11,226 Intera 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 risk of significant injury or property damage, meeting the criteria for a Severe rating.
Plain-English summary
Philips Medical Systems Nederlands is recalling 11,226 Intera 1.5T R11 Nuclear Magnetic Resonance Imaging Systems, Model Number 781170. The recall covers all systems distributed nationwide in the United States.
The recall is due to a potential safety hazard where ceiling speakers may fall from their position and be pulled toward the MRI system by the magnetic field. This presents a risk of injury or property damage if the speakers detach.
Healthcare facilities and consumers should contact Philips Medical Systems Nederlands for instructions on how to address this issue. The agency has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System
- Manufacturer
- Philips Medical Systems Nederlands
- 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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