Philips T10-NT MRI Systems Recalled for Helium Gas Risk
Philips is recalling 8,205 T10-NT MRI systems due to a potential risk of helium gas release in 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 involves a risk-of-harm product (asphyxiation risk from helium gas) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling 8,205 units of the T10-NT, Model 78107 MRI diagnostic devices. These devices are indicated for use as diagnostic tools to produce cross-sectional images, spectroscopic images, and spectra of the internal structure 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 across the United States and numerous international locations.
Healthcare facilities and consumers should contact Philips for further instructions regarding the recall and necessary corrective actions.
The recalled product
- Product
- T10-NT, Model 78107 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 Systems
- Hazard
- 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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