The FDA says a recall of Philips
(NYSE: PHG)
Panorama 1.0T HFO magnetic resonance imaging (MRI) systems is Class I, the most serious kind.
Philips recalled the MRI system due to a risk of explosion during a quench procedure. The excessive pressure buildup of helium gas could cause this.
To date, Philips has received reports of one explosion event in 22 years of use. It reports no injuries or death related to this issue.
There has been one reported event of an explosion in 22 years of use. There have been no reports of injury or death.
During a quench — which Philips said is “not common” — a large amount of helium evaporates and vents outside the building through a venting system. If an unknown blockage is present in the venting system and the pressure exceeds design limits, it could compromise the structural integrity of the system.
Philips says the magnet in the MRI system may experience an unintended quench during normal use. It may occur when initiated in an emergency by the operator pressing the “Magnet EMERGENCY STOP” button.
Using an affected system could lead to chemical exposure, lack of oxygen, tissue damage and mechanical trauma caused by debris. Consequences may include brain injury, laceration, fracture, eye injury, bruises and death. It could also lead to system or property damage.
Philips distributed affected devices between Jan. 1, 2001, and Oct. 1, 2016. It recalled 150 devices in the U.S. after initiating the recall on Nov. 20, 2023, according to the FDA notice.
Instructions from Philips and a company statement
Philips’ urgent medical device correction notice told customers to immediately discontinue use of any impacted systems. Users also should not initiate a manual quench of the magnet unless an emergency takes place.
Customers should also post a “do not use” notice on or near the impacted systems and circulate the warning to all users of the device to ensure they are aware. Philips plans to have a field service engineer visit all U.S. customers and inspect the system, performing corrective replacement or repair, if necessary.
A Philips spokesperson said that, since the Panorama 1.0T HFO MRI system in 2005, it received one report of system and property damage. This occurred during a decommissioning magnet quench procedure in which Philips guidelines were “reportedly not followed.”
Philips stopped producing the affected product line in 2014. There are approximately 340 units globally, of which 150 are in the U.S.
The company said it notified all customers with operational systems and inspected around 80% of the systems already. Globally, approximately 85% of customers have been contacted and about 75% of systems have been inspected. Philips expects to complete inspections in 2023.
“Philips’ priority is patient safety and quality,” the company statement says. “The notification instructs customers to stop using the Panorama 1.0T HFO MRI system and to refrain from initiating a magnet quench procedure until a system inspection by Philips field service engineers has been completed.”