Philips Achieva 1.5T MRI Systems Recalled for Helium Gas Risk
Philips is recalling 8,205 Achieva 1.5T 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 (MRI system) where injury has not yet been reported, which aligns with the 'High' severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Philips Electronics North America Corporation is recalling 8,205 units of the Achieva 1.5T MRI system. The affected models include the Nova (Dual), Initial Systems, Nova, Conversion, R5 based, and other specific model numbers listed in the official recall documentation. These devices are indicated for use as diagnostic devices to produce cross-sectional images and spectra 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. A magnet quench is a rapid loss of the magnetic field, which can result in the release of helium gas. The source text does not specify the exact mechanism of failure or the volume of gas released, only the potential risk associated with the event.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international locations. The source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare facilities should contact Philips for further instructions on how to address this potential safety risk.
The recalled product
- Product
- Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 8,205
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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