Philips Multiva MRI Systems Recalled for Helium Gas Quench Risk
Philips is recalling 8,205 Multiva MRI systems worldwide due to a potential risk of helium gas release during a magnet quench.
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 (potential asphyxiation from helium gas) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling 8,205 units of Multiva MRI systems, including specific models of Magnets Multiva 16, Magnets 8, Magnet Achieva 1.5T, Magnet HFO, and Magnets Ingenia 1.5T CX. These diagnostic devices are indicated for use in producing cross-sectional and spectroscopic images of the head, body, or extremities.
The recall is issued due to a potential risk for helium gas inside the MR examination room during a magnet quench. The affected units were distributed worldwide, including nationwide in the United States and in numerous international locations.
The source text does not specify the corrective actions consumers or facility operators should take, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498 Product Usage:
- Manufacturer
- Philips Electronics North America Corporation
- Hazard
- Affected units
- 8,205
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)
- None
Distribution
Part of a larger recall action
This product is one of 13 recalled by Philips Electronics North America Corporation 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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