340 MRI machines manufactured by Philips are being recalled due to a potential risk of explosion

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Senior Radiologist Controls MRI

Hundreds of MRI machines worldwide are being recalled by Philips due to fears that they may explode during regular use. The US Food and Drug Administration has reported one previous incident of this occurring.

The FDA has issued a recall notice this week for a specific type of MRI machine, the Philips Panorama 1.0T HFO. This is considered a “class one” recall, which is the most severe kind. If you own one of these machines, it is important that you stop using it immediately and arrange for a service technician to perform necessary repairs. The announcement can be found on the FDA’s website.

In use from 2001 to 2016, these machines are widely utilized by medical institutions worldwide for visualizing the internal organs of patients. Currently, there are 150 Panorama 1.0T HFO machines in operation within the United States and a reported total of 340 globally.

The recall was prompted by a discovery made during the “quench”, when the magnet coils lose their superconductivity due to reaching higher temperatures than near-absolute zero. It was determined that in this state, the helium gas responsible for cooling the coils evaporates and can potentially lead to device ruptures.

The bulletin states that if the gas cannot be vented, it may cause equipment to explode. This could potentially lead to property damage and/or serious harm, including chemical exposure, oxygen deprivation, tissue damage, and physical injury.

According to the recall, in the event of a rare quench occurrence, a significant quantity of helium is released and expelled from the building through a specialized venting mechanism. However, if an obstruction is present within this system and the pressure surpasses its intended capacity, it may potentially compromise the overall structural stability of the system.

Although infrequent and not ideal, a quench may still happen during regular use due to unforeseen issues or be initiated by an operator using the magnet emergency stop button in critical situations.

As per the FDA report, there has been only one incident in 22 years where an explosion occurred during a quench operation. Fortunately, there were no injuries reported.

According to Philips, all impacted customers have been informed of the recall and will receive a visit from a field service engineer for system inspection and necessary corrective actions. The specific alterations made are unclear. Non-US customers are advised to reach out to Philips within 30 days of the notification.

This recent recall adds to the list of setbacks for Philips, which is still dealing with the fallout from a previous recall and resulting class action lawsuits pertaining to its Respironics products.

In June 2021, a recall was issued by the manufacturer for various ventilators, BiPAP and CPAP machines. The reason for this action is the potential health risks associated with dissolving polyurethane foam, which may fragment and be inhaled by users.

 

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