Philips MRI Software Recall Due to Helium Gas Risk During Quench
Philips is recalling the SmarthPath to dStream conversion software for 1.5T MRI systems 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 software) where injury has not yet been reported, fitting the 'High' severity criteria for potential hazards without confirmed adverse events.
Plain-English summary
Philips Electronics North America Corporation is recalling the Conversion SmarthPath to dStream for 1.5T, Model 781260. This software is indicated for use as a diagnostic device that produces cross-sectional images, spectroscopic images, and/or spectra of the internal structure of the head, body, or extremities.
The recall is being issued because of a potential risk for helium gas inside the MR examination room during a magnet quench. A magnet quench is a sudden loss of the magnetic field, which can release the helium gas used to cool the magnet.
A total of 8,205 units were distributed worldwide, including in the United States and numerous international locations. The source text does not specify the number of reported injuries or illnesses associated with this recall. Users of this software should contact Philips for further instructions on how to address the potential safety risk.
The recalled product
- Product
- Conversion SmarthPath to dStream for 1.5T, Model 781260 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 Software
- 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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