BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Safety Notice for Agfa HealthCare IMPAX® Cardiovascular (IMPAX CV) products, Agfa HealthCare

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 05888/12

Agfa HealthCare has issued a Field Safety Notice concerning of a problem with Agfa HealthCare IMPAX® Cardiovascular (IMPAX CV) products.
DICOMstore together with MDP or CPS provides a mechanism to manage the images in IMPAX CV for proper storage, retrieval and purge. Agfa HealthCare has determined that under certain circumstances misconfiguration of DICOMstore has occurred, allowing for the inadvertent deletion of patient data.

Safety Notice for Agfa HealthCare IMPAX® Cardiovascular (IMPAX CV) products, Agfa HealthCare , Download_VeroeffentlichtAm_EN PDF, 50KB, File does not meet accessibility standards