Philips Achieva 3.0T MRI System Recalled for Falling Speaker Hazard
Philips is recalling 11,226 Achieva 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 in a medical setting) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems Nederlands is recalling 11,226 Achieva 3.0T X-series Nuclear Magnetic Resonance Imaging Systems, Model Number 781277. 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.
The affected units were distributed nationwide in the United States. The recall covers all systems of this specific model.
Healthcare facilities should contact Philips Medical Systems Nederlands for instructions on how to address this issue. The source text does not specify a remediation method or a deadline for action.
The recalled product
- Product
- Achieva 3.0T X-series, Model Number 781277. 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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