Philips Recalls Medical Imaging Device Due To A Risk Of Explosion; FDA Identifies Recall As Most Serious Type

Koninklijke Philips N.V. PHG has recalled some Panorama 1.0T HFO machines. The magnetic resonance (MR) system is used to take different kinds of images that show what's inside the body and can help health care providers make a diagnosis.

About 150 devices in the U.S. are being recalled, with distribution dates between January 1, 2001, and October 1, 2016, according to a statement by the FDA yesterday.

Philips North America LLC has recalled the devices due to the risk of explosion during a quench procedure caused by excessive pressure buildup of helium gas.

The FDA has identified this as a Class I recall, the most serious type of recall.

During a quench, a large amount of helium evaporates and is vented outside the building through a venting system.

If the venting system has a blockage and the pressure exceeds design limits, the structural integrity of the system could be compromised. 

The magnet in the Panorama 1.0T HFO may experience an unintended quench during normal use or when the operator presses the Magnet EMERGENCY STOP button.

The affected system, when used, may lead to chemical exposure, lack of oxygen, tissue damage, and mechanical trauma caused by debris, such as brain injury, laceration, fracture, eye injury, bruises, and death. 

There has been one reported event of an explosion in 22 years of use. There have been no reports of injury or death. There have been no reports of injury or death. 

All U.S. customers will be visited by a Philips field service engineer who will inspect the system and perform corrective replacement or repairs, if necessary.

Price Action: PHG shares traded lower by 0.70% at $22.81 on the last check Thursday.

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