Philips Intera 1.0T MRI Systems Recalled for Helium Gas Risk
Philips is recalling 8,205 Intera 1.0T MRI systems worldwide 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 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 Intera 1.0T MRI systems, specifically the Stellar Model 781102 and Pular Model 781103. These diagnostic devices are indicated for producing cross-sectional and spectroscopic images of the head, body, or extremities. The recall is due to a potential risk of 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. The recall notice identifies specific serial codes associated with the affected units, which were added to the record on June 25, 2018.
Healthcare facilities and users of these devices should contact Philips Electronics North America Corporation for further instructions on how to address the potential helium gas risk. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 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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