Software issues prompt recall of nearly 11,000 interventional systems
A Class 2 recall has been issued for a series of interventional fluoroscopic systems manufactured by Philips.
The recall, which pertains to the Azurion R2.2.10, was issued due to a software glitch that could cause the degradation of image quality or the loss of geometric movements. Each has the potential to cause “image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment,” according to a notice released by the U.S. Food and Drug Administration.
In mid-July, Philips sent out Urgent Medical Device Correction letters to affected customers. The notices further described the issues and the potential complications that could arise as a result. They also provided instructions on how customers can continue to safely use the equipment while waiting for a software update.
For the image quality issue, Philips offered the following advice:
If image quality degradation is observed, perform a cold restart of the system as soon as clinically feasible.
On the review module, press and hold "power off."
Release the button when the indicator light begins to flash.
When the indicator light stops flashing, wait for 10 seconds.
On the review module, press and hold "power on."
It can take up to six minutes from the time the system is restarted before it is fully functional again.
For the loss of geometry movements, the company advised the following:
If loss of geometry movements is observed, restart the geometry following the steps described in the Instructions.
On the control module, press the "emergency stop" button.
On the review module, press the "power on" button for approximately 2 seconds.
This process can take around two minutes to restore functionality.
Philips recommends that affected customers post these instructions where users can easily view them. A software update is expected to fix the issues, but anyone who encounters them in the meantime is encouraged to contact their local Philips representative.
Nearly 11,000 units worldwide are impacted by the recall.
More detailed information can be found here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.