Over 150 Panorama 1.0T HFO MRI Scanners are being recalled by Philips North America LLC over explosion risks. Feared to be caused by excessive helium gas buildup, the explosions can be life-threatening to both the patient and care providers.
The voluntary recall issued on December 20 exclusively applies to the Panorama 1.0T HFO MRI Scanners which are based on magnetic resonance (MR) systems and are widely used at medical centers and labs to scan the body of the patients. The scanned results are presented in the form of detailed digital images which can be used by the health care providers for diagnosis.
As per the establishment, the affected MRI scanners may sometimes go through a 'quench procedure' that is known to generate massive amounts of helium. While this gas usually evaporates and gets vented out of the building through a venting system, it may sometimes fail to do so if there's a blockage in the venting system.
It is to be noted that the magnet equipped in the Philips Panorama 1.0T HFO scanners may go through unintended quench procedures on its own or when the Magnet Emergency STOP button is pressed by the operator. In case the helium fails to vent through the system, it may lead to excessive pressure build-up and compromise the structural integrity of the system, thus posing risks of an explosion.
All you need to know about the Philips Panorama 1.0T HFO MRI Scanner recall
At least 150 Panorama 1.0T HFO MRI Scanners produced by Philips are part of a 'Class 1' recall initiated this Wednesday. Feared to pose risks of an explosion, the affected medical devices may cause both the patients and the caregivers to experience serious to life-threatening injuries or even death.
The establishment has already informed the United States Food and Drug Administration (FDA) about at least one explosion incident linked to the Panorama 1.0T HFO MRI Scanner. While the explosion is reported to have resulted in some property and system damages, there were no reports of an injury or casualty. It is to be noted that the concerned scanners have been in use for over 22 years and this was the first reported explosion.
The Panorama 1.0T HFO MRI Scanners affected by the recall came with the product code 'LNH' and were available under two model numbers - 781250 and 781350. Distributed across the United States between January 1, 2001, and October 1, 2016, the recalled MRI Scanners were officially discontinued in 2014.
Considering the graveness of the problem, Philips North America LLC has already sent an 'URGENT Medical Device Correction' notice to all affected customers. The notice urges all healthcare institutes using the Panorama 1.0T HFO MRI Scanners to discontinue the usage.
Health-care providers are also urged not to initiate manual quench procedures unless it's an emergency. The establishment will be sending a field service engineer to all United States consumers. The engineer will not only inspect the affected scanners but will also perform all corrective repairs and/or replacements if required.
Individuals with queries about the recall or the remedy can reach out to the Philips Customer Care Solutions Center at 1-800-722-9377.