Philips warns on unintended radiation with imaging systems

August 21, 2023 By Sean Whooley

Philips (NYSE: PHG) + issued an urgent field safety notice in Europe regarding a potential issue with some of its imaging systems.

The issue pertains to the wired and wireless foot switches used with the Philips Allura Xper, Allura Centron, Azurion and the MultiDiagnost-Eleva systems. It could lead to unintended radiation, according to the notice filed in Europe this month.

Philips’ notice says the foot switches control fluoroscopy, exposure and other functions. These include single shot, light control and toggle between X-ray planes. A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in unintended radiation. The company received no reports of harm related to the issue.

This issue can occur with a build-up of dense or sticky fluids on the switch if not properly cleaned. Philips also said it may happen with the use of protective covers that are the wrong size or are incorrectly placed on the switch. Dislodgement of a screw holding the pick-up bar of the switch can also lodge within the switch housing, causing the issue.

An additional screw inadvertently left in the switch housing during manufacturing can also lead to the problem, Philips said.

Unintended radiation can lead to limited/transient radiation effects in the population at greatest risk. This could include pediatric patients, pregnant women and patients with existing radiation effects. Philips considers long-term effects unlikely, though.

Additionally, a sticking foot switch may result in a procedural delay. Philips considers the probability of medically reversible or transient adverse health consequences in this instance “remote.”

The company included actions for preventing risk or harm in its instructions for use. Philips also plans to conduct visits to inspect switches and provide the amended instructions. Customers may continue to safely use affected devices in accordance with those instructions.

Filed Under: Health Technology, Imaging, Radiosurgery/Radiation therapy, Recalls, Regulatory/Compliance Tagged With: Philips