BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Safety Notice concerning certain software versions of FDR AcSelerate X-ray system, Fujifilm

Product group Radiological technology
Reference 04352/11

Fujifilm has issued a Field Safety Notice concerning certain software versions of FDR AcSelerate X-ray system. When Tomography function is used there is a potential risk of an over or under exposition for the patient. The users are advised to stop using the Tomography function immediately until a software upgrade is implemented. Germany is not affected.

Safety Notice concerning certain software versions of FDR AcSelerate X-ray system, Fujifilm , Download_VeroeffentlichtAm_EN PDF, 77KB, File does not meet accessibility standards