Philips interventional systems recalled due to software glitch
Thousands of Philips interventional fluoroscopy systems are included in a new Class 2 recall issued by the U.S. Food and Drug Administration.
A Nov. 6 notice indicates that the systems were recalled due to a software issue that can cause certain features to fail during imaging; this is specific to the Allura interventional fluoro systems. The FDA notice says that the glitch may “cause the FlexVision software application to become unresponsive during clinical use.”
Philips Medical first alerted impacted customers about the issue in October. The Urgent Medical Device Correction notifications indicated that the systems may continue to be used; the letters also provide users with information on how to potentially work around the glitch in the meantime.
Those instructions are as follows:
If the FlexVision monitor becomes blank or freezes on the last displayed screen during a procedure, suspend image-guided device manipulations and perform a cold system restart.
Press the System OFF button on the Xper review module for more than 10 seconds.
The system performs a controlled shutdown.
Press the System ON button on the Xper review module.
Philips says it intends to make the correction via software update to users free of charge. However, the company indicated that repairs will not commence until July of 2028. A Philips representative will reach out to impacted users to coordinate that.
It is estimated that nearly 3,400 systems have been impacted globally.
Read more 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.