Philips to issue corrections for thousands of interventional fluoroscopy systems

The U.S. Food and Drug Administration recently issued a class 2 recall for thousands of interventional fluoroscopy systems manufactured by Philips. 

The Philips Allura interventional fluoro systems were recalled due to the potential for imaging capture malfunctions, lack of motorized movement and loss of data due to “unauthorized hard disk drives,” according to a notice from the FDA. The exact cause has not yet been determined, but Philips is already taking steps to ensure they do not persist for long. 

In June, the company issued Urgent Medical Device Correction notices to impacted customers. The letters offered details on how to continue using the systems while waiting for a resolution. 

They company shared the following in the notices: 

• If motorized movements are unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. 

• For ceiling-mounted systems, manual longitudinal, transversal and rotational stand movements remain available. However, transversal stand movements are only available for ceiling-mounted systems with the FlexMove option. 

• For floor-mounted systems, only rotational stand movements remain available. The table's longitudinal position can be adjusted manually, when the table is not tilted. 

Philips intends to inspect all affected systems and will likely replace their hard drive disks; it also will correct configurations where different disks types are used within a single system. The company expects these corrections to be implemented starting in September. 

Nearly 10,000 units throughout the U.S. are believed to be impacted, but no adverse events related to the recall have been reported. 

More information can be found here.