Sam Brusco, Associate Editor12.21.23
The U.S. Food and Drug Administration has identified Philips’ November 20 recall of its Panorama 1.0T HFO MR (magnetic resonance) system as Class I.
Philips recalled the MR devices because of an event in which the structural integrity of the MR system components failed, due to unintended excessive pressure buildup of helium gas during a magnet quench.
During a quench of the MR magnet (which Philips said isn’t common), a large amount of helium evaporates and vents outside the building through a venting system. The company explained that the venting system’s structural integrity might be compromised if there’s an unknown blockage and pressure rises too high.
Philips explained that Panorama’s magnet may experience unintended quench during normal operation or when initiated in an emergency by pressing the emergency stop button. Possible adverse health consequences from an explosion due to unknown vent blockage can include chemical exposure, lack of oxygen, tissue damage, or trauma caused by debris.
Philips said this was the first explosion event in 22 years of use, with no reports of injury or death. 150 devices were recalled in the U.S.
The company’s November 17 Urgent Medical Device Correction Notice requested users immediately discontinue use of impacted MR systems, only start a manual quench in emergencies, and place a “do not use” notice on or near the MRI until inspections are made.
Philips said a field service engineer will be deployed to inspect the Panorama machine and make repairs as needed.
Philips recalled the MR devices because of an event in which the structural integrity of the MR system components failed, due to unintended excessive pressure buildup of helium gas during a magnet quench.
During a quench of the MR magnet (which Philips said isn’t common), a large amount of helium evaporates and vents outside the building through a venting system. The company explained that the venting system’s structural integrity might be compromised if there’s an unknown blockage and pressure rises too high.
Philips explained that Panorama’s magnet may experience unintended quench during normal operation or when initiated in an emergency by pressing the emergency stop button. Possible adverse health consequences from an explosion due to unknown vent blockage can include chemical exposure, lack of oxygen, tissue damage, or trauma caused by debris.
Philips said this was the first explosion event in 22 years of use, with no reports of injury or death. 150 devices were recalled in the U.S.
The company’s November 17 Urgent Medical Device Correction Notice requested users immediately discontinue use of impacted MR systems, only start a manual quench in emergencies, and place a “do not use” notice on or near the MRI until inspections are made.
Philips said a field service engineer will be deployed to inspect the Panorama machine and make repairs as needed.