Philips T5-NT MRI Scanner Recalled for Helium Gas Risk
Philips is recalling 8,205 T5-NT MRI scanners worldwide 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 (MRI scanner) where injury has not yet been reported, fitting the 'High' severity criteria for potential hazards without confirmed illness or injury.
Plain-English summary
Philips Electronics North America Corporation is recalling 8,205 units of the T5-NT, Model 78104 MRI scanner. The device is indicated for use as a diagnostic device to produce cross-sectional images, spectroscopic images, and/or 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 the United States and numerous international locations.
Healthcare facilities should contact Philips for instructions on how to address the potential hazard. Specific serial numbers or lot codes for the affected units are listed in the agency's recall record.
The recalled product
- Product
- T5-NT, Model 78104 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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