Philips North America is recalling 150 MRI machines in the U.S. due to explosion risks. The FDA has classified the recall as a Class 1, the most serious type of recall.
Two models of the Panorama 1.0T HFO MRI scanners were affected by the recall, and Phillips began notifying customers Nov. 20, urging them to discontinue use. The risk of explosion is related to a blockage issue with the machine that can cause an excessive pressure buildup of helium gas during what's known as a quench procedure. The models affected were distributed between January 2001 and Oct. 1, 2016.
"The use of an affected system may cause serious adverse health consequences," the company said in a Dec. 20 recall notice published on the FDA's website. "The issue could also lead to system or property damage."
In the past 22 years, Philips said it has received one report of an explosion event and no reports of injury or death.
"Philips is actively reaching out to customers to ensure awareness of the notification, and to schedule and carry out system inspections as expeditiously as possible," a spokesperson told Becker's Dec. 21.
In the U.S., all organizations with affected MRI machines have been notified, and about 95% have already been inspected and can be put back into use, according to Philips. The company said it plans to complete all remaining inspections by the end of this year.
Over the past few years, Philips has issued a number of recalls and safety alerts related to its sleep apnea products, affecting millions of products.