(Dec 21): Royal Philips NV recalled an MRI device as the US Food and Drug Administration (FDA) raised concerns about a risk of explosion, adding to the company’s woes as it fights litigation over sleep apnea gear.

The Dutch medical equipment maker issued a voluntary recall of its Panorama 1.0T HFO magnetic resonance imaging (MRI) system due to a problem related to excessive pressure buildup of helium gas. In a worst-case scenario this could lead to a rupture with enough force to result in property damage or injury, Philips said in a statement.

The firm’s shares fell as much as 2.7% and were trading 1.9% lower at €20.90 (RM106.77) apiece as of 9.48am in Amsterdam.

The FDA identified the recall as Class I, the most serious type, adding that there has been one reported event of an explosion. The company said that the incident occurred during a “procedure where Philips guidelines were reportedly not followed.”

The announcement adds to long-standing recall struggles with Philips sleep therapy products. For more than two years the company has been recalling some devices over health concerns related to disintegrating noise-dampening foam. Since the company first flagged quality issues with certain sleep and respiratory-care products in June 2021, the shares have dropped more than 50%.

“Even if limited in nature, this is another Class I recall,” putting Philips in the spotlight again for quality and safety issues, Jefferies International analysts including Julien Dormois said in a report.

There are around 340 Panorama systems globally, of which 150 units are in the US, the company said.

Philips said there have been no reports of patient or user injury or serious harm to date with the device. The firm has notified all of its customers in the US and plans to complete inspections of the recalled system in 2023.