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Recall of Philips imaging devices ‘most serious’: USFDA says

The US drug regulator has termed its Class I recall of Philips magnetic resonance systems as the “most serious” type.

HQ Team

December 21, 2023: The US drug regulator has termed its Class I recall of Philips magnetic resonance systems as the “most serious” type.

The US Food and Drug Administration stated that the use of Panorama 1.0T HFO devices could result in serious injuries or death.

The Panorama 1.0T is a magnetic resonance (MR) system — a machine used to take different kinds of images. These images show what’s inside the body and can help healthcare providers make a diagnosis.

Philips North America LLC is recalling the device “due to the risk of explosion during a quench procedure caused by excessive pressure buildup of helium gas,” according to an FDA statement.

A quench is an event when helium is quickly released from the MR machine, causing the machine to be non-superconductive or lose its magnetic field.

Helium evaporation

During a quench, which is not common, a large amount of helium evaporates and is vented outside the building through a venting system.

Quenching an MR machine is performed only in dire circumstances. It can occur by accident, which is spontaneous, or manually by pressing the emergency quench button.

“If an unknown blockage is present in the venting system and the pressure exceeds design limits, the structural integrity of the system could be compromised,” according to the FDA.

The magnet in the Philips device may experience an unintended quench during normal use or when initiated in an emergency by the operator.

The use of an affected system may cause serious adverse health consequences.

Lack of oxygen

The effects include chemical exposure, lack of oxygen, tissue damage, and mechanical trauma caused by debris, such as brain injury, laceration, fracture, eye injury, bruises, and death. 

The issue could also lead to system or property damage. There has been one reported event of an explosion in 22 years of use. There have been no reports of injury or death.

Healthcare providers using the Panorama 1.0 system to obtain detailed pictures or measurements of the inside of the head, body, or limbs from different angles were at risk, and so were people in the vicinity of the system when such an incident took place.

Philips North America LLC, on November 20, 2023, sent all affected customers an urgent Medical Device Correction notice and requested customers to immediately discontinue the use of any impacted MR systems.

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