Topic archive
MedTech Current publications and recall entries tagged Diagnostic Imaging.
Measurement errors in a diagnostic imaging workstation can affect interpretation even when source images remain available. The mitigation combines retrospective study identification, cross-checking against modality measurements, and a software update.
Bolus Tracking coordinates contrast enhancement with CT image acquisition, so failure to trigger the clinical scan can disrupt an imaging workflow at a critical step. The event also demonstrates a software correction handled under radiation-product requirements, making it relevant to both imaging-service operations and regulatory teams responsible for radiological systems.
Azurion systems support image-guided interventional procedures, so software failures affecting both imaging and equipment movement can create immediate procedural and workflow consequences. Grouping the two FDA records also illustrates why product-version records with substantially identical failure modes and corrective instructions should be treated as one editorial event.
Loss of geometry movement in an interventional fluoroscopic system can disrupt procedure workflow even when imaging remains available. The event is relevant to hospitals because the permanent correction is a future software installation, requiring users to retain and post interim instructions, recognize the failure mode, and use the specified restart process meanwhile.