Philips MRI System Recall Due to Ceiling Speaker Magnetic Hazard
Philips is recalling Intera Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
What this means for you
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 clinical setting) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness or injury.
Plain-English summary
Philips Medical Systems Nederlands is recalling Intera Achieva 1.5T Nova Dual MRI systems, Model Number 781173. 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 using these systems should contact Philips Medical Systems Nederlands for instructions on how to address the issue. The source text does not specify a deadline or additional remediation steps.
The recalled product
- Product
- Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System
- Manufacturer
- Philips Medical Systems Nederlands
- Category
- Medical Device — MRI Systems
- 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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