Philips has issued an urgent field safety notice for several of its fluoroscopy and angiography systems due to the potential of foot switches becoming stuck in the active position, resulting in unintended radiation to patients.
"Philips has become aware of a potential safety issue with the wired and wireless foot switch used with the Philips Allura Xper, Allura Centron, Azurion, and MultiDiagnost-EIeva systems, where there is a possibility of unintended radiation," the company said, in a recent notice to customers.
The imaging systems are used primarily in fluoroscopy and angiography exams during interventional radiology procedures. The foot switch is a user-input device with different foot pedals for these functions:
- Initiating x-ray radiation (fluoroscopy, series exposure, or single shot).
- Controlling other functions, such as examination room light, or, in case of a bi-plane system, toggling between frontal and lateral x-ray planes.
A stuck foot switch may result in unintended radiation exposure to the patient, which could contribute to the development of radiation effects in the population at greatest risk from use of the systems, including pediatric patients, pregnant women, and patients with existing radiation concerns, the company said.
In addition, resolving a stuck foot switch during a procedure (e.g., adjusting the switch to become unstuck) could result in a procedural delay, although adverse health consequences due to this are considered remote, Philips said.
No reports of harm resulting from stuck foot switches have been received. The company has included instructions in its notice for cleaning the foot switch and using protective covers to mitigate the issue.
Philips also said it will conduct visits to inspect switches and provide instructions on safe use of the devices.
