Philips Medical Systems Nederland B.v.: Interventional Fluoroscopic X-ray System

Recall Summary Philips Allura and Cardio Vascular-Allura Centron interventional fluoroscopic X-ray systems (Model 722400) are being recalled nationwide due to the use of unauthorized hard disk drives that may cause loss of imaging capability, motorized movement failure, or data loss. The recall affects medical facilities across all U.S. states and the District of Columbia. This is classified as a Class II recall.

Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Reason
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-06-17
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide distribution.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/78ff642c-8de4-4799-94a3-ffad2f0e2b48