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Philips recalls Panorama 1.0T MR over potential quench hazard

por Gus Iversen, Editor in Chief | December 27, 2023
MRI
Philips Panorama 1.0T HFO MR system
Philips has issued a voluntary recall for its Panorama 1.0T HFO MR scanner due to a potential magnet quench hazard, which the FDA has identified as a Class I recall, the most serious type.

There are approximately 340 Panorama units globally, of which 150 are in the U.S. Philips stopped producing and selling the Panorama 1.0T HFO product line in 2014.

In the U.S., all customers with operational Panorama systems have been notified and, as of last week, ~80% of the systems had been inspected. In the rest of the world, ~85% of the customers with operational systems have been contacted and ~75% of the systems have been inspected. In a December 20 statement, Philips said it planned to complete the inspections before the end of the year.
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During a magnetic quench procedure, a large amount of helium evaporates and is vented outside the building through a venting system. If an unknown blockage is present in the venting system and the pressure exceeds design limits, in a potential worst-case event, there is a possibility of a rupture with sufficient force to result in property damage or injury.

So far, there have been zero reports of patient, user or bystander injury or serious harm to date. Since the launch of the Panorama 1.0T HFO MR system in 2005, there has been one report of system and property damage, which occurred during a decommissioning magnet quench procedure where OEM guidelines were reportedly not followed, according to Philips.

Philips is instructing customers to stop using the scanner and to refrain from initiating a magnet quench procedure until a system inspection by Philips field service engineers has been completed.

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