Philips MRI System Recall Due to Ceiling Speaker Fall Risk
Philips is recalling Intera 1.5T Achieva CV Nova 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 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 the Intera 1.5T Achieva CV Nova, Model Number 781174, Nuclear Magnetic Resonance Imaging (MRI) systems. The recall involves 11,226 units that were 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 hazard could result in 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 the issue with the ceiling speakers. Users should follow the manufacturer's guidance to ensure the safety of the MRI environment.
The recalled product
- Product
- Intera 1.5T Achieva CV Nova, Model Number 781174. 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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