Philips T5 MRI Scanner Recalled for Helium Gas Risk
Philips is recalling T5 MRI scanners 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 (asphyxiation risk from helium) 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 T5 Model 78104 MRI diagnostic device. The recall is issued because of a potential risk for helium gas inside the MR examination room during a magnet quench.
The affected devices are indicated for use as diagnostic devices to produce cross-sectional images, spectroscopic images, and/or spectra of the internal structure of the head, body, or extremities. The recall covers units distributed worldwide, including the United States and numerous international locations.
Healthcare facilities should contact Philips for instructions on how to manage the recall and ensure patient safety during the investigation of this potential hazard.
The recalled product
- Product
- T5 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
- 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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