Philips Panorama 1.0T MRI Recalled for Helium Gas Release Risk
Philips is recalling Panorama 1.0T MRI scanners due to a potential risk of helium gas release into the examination room 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 is classified as FDA Class II, and the hazard involves a risk of harm (helium gas release) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling the Panorama 1.0T MRI scanner, Model 781250. This diagnostic device is indicated for use in producing cross-sectional images, spectroscopic images, and/or spectra of the head, body, or extremities.
The recall is issued because of 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 used to cool the magnet.
A total of 8,205 units are affected by this recall. The devices were distributed worldwide, including in the United States and numerous international locations. Users of these devices should contact Philips for further instructions on how to address this issue.
The recalled product
- Product
- Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — MRI Scanner
- 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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