Philips Panorama MRI Machine Recall Issued Over Explosion Risk
FDA has given the Philips Panorama MRI machine recall a Class I designation, indicating the devices put patients and others at risk of severe injury and death.
A Philips Panorama MRI machine recall has been announced, following reports of an explosion caused by helium gas trapped in the system.
The U.S. Food and Drug Administration (FDA) announced the Philips Panorama 1.0T HFO MRI system recall on December 20, impacting 150 units used in medical facilities nationwide.
The Panorama 1.0T is a magnetic resonance system used to take different types of medical imaging for patients. The images help doctors see things occurring inside the human body, helping diagnose patients.
Panorama MRI Explosion Risks
Philips North America LLC said the recall was issued due to the risk of the MRI machines exploding during what is known as a quench procedure. This can be caused by excessive pressure buildup of helium gas.
During a quench procedure, significant amounts of helium build up and evaporate. The excess helium is vented outside the building through a venting system. However, if there’s a blockage in the venting system and the pressure exceeds design limits, the integrity of the system could be compromised during the quenching procedure.
This may lead to serious side effects, including chemical exposure, lack of oxygen, tissue damage, and injury caused by debris, such as brain injury, laceration, fracture, eye injury, bruises, and death. It could also cause property damage.
An unexpected quench can occur during normal use of the Panorama MRI machine or can be intentionally initiated by the operator during an emergency situation.
The MRI recall was issued after a quench occurred on a machine that led to an explosion. There are no reports of injury or death. Philips indicated this is the first reported explosion occurring in 22 years of use.
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Learn MorePhilips Panorama MRI Recall
The recall affects Philips Panorama 1,0T HFO MRI systems, model numbers 781250 and 781350, distributed from January 1, 2001, to October 1, 2016.
Philips originally issued a product correction for the devices on November 20. The recall is not removing products from the U.S. market. Instead, the company is conducting a product correction for affected devices.
However, the FDA has now designated the action a class I recall, the most serious recall classification, indicating that the FDA believes using the affected devices could lead to serious injury or death.
Philips urged health care providers to immediately stop using affected Philips MRI systems, since this is a type of medical device that is used daily to help diagnose and treat patients. The manufacturer also warned operators to not initiate a manual quench procedure of the MRI magnet unless there is an emergency.
Customers are instructed to post a warning notice on or near the impacted MRI systems. A Philips field service engineer will visit all U.S. customers to conduct an inspection of the MRI system and perform corrective repairs, if necessary.
Customers affected by adverse events or problems with the system are urged to report occurrences to the FDA’s MedWatch Adverse Event Reporting program.
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