Philips Ingenia 1.5T CX MRI Recall for Helium Gas Risk
Philips is recalling Ingenia 1.5T CX MRI scanners due to a potential risk of helium gas release into 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 is classified as FDA Class II. The hazard involves a potential release of helium gas, which poses a risk of harm (asphyxiation or cold burns) but the source does not report any confirmed illnesses or injuries, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips Electronics North America Corporation is recalling the Ingenia 1.5T CX MRI scanners, Models 781261 and 781262. The recall involves 8,205 units distributed worldwide, including across the United States and numerous international locations. These devices are indicated for use as diagnostic imaging equipment for the head, body, and extremities.
The recall is issued due to a potential risk of helium gas being released inside the MR examination room during a magnet quench. A magnet quench is a rapid loss of the magnetic field, which can result in the release of the cryogenic helium used to cool the magnet. The source text does not specify the exact mechanism of the failure or the specific corrective actions required for the units.
Healthcare facilities and users of these devices should contact Philips Electronics North America Corporation for instructions on how to address the potential hazard. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Ingenia 1.5T CX, Models 781261 & 781262 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
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- (Added 6/25/18): 41158 70743 70200
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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