Recall Z-0101-2019 ยท LLZ System, Image Processing, Radiological
Agfa Healthcare NV
Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes withi
| Date | Aug 3, 2018 |
| Status | Terminated |
| Reason | Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thumbnail images of the studies are no longer chronologically sorted with the most recent study at the top. |
| Root cause | Software design |
| Action | The firm, Agfa, sent an "URGENT FIELD SAFETY NOTICE Medical Device Recall" Notice dated 8/3/18 to its customers. The notification described the product, problem and actions to be taken. The notification letters instructed customers to do the following: 1. Please instruct your users to pay extra attention when selecting a study in the Clinical Side Bar to be sure they are reporting on the active study and not on one of the comparison studies. The active and comparison study are clearly differentiated from each other via blue (active) and grey (comparison) icons in both the Text and Image Ar |
| Quantity | 17 |
| Distribution | US distribution to states of: CA, FL, IN, LA, MN, PA, SC, TX, VA, and Puerto Rico and internationally to: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111945 | IMPAX NEXT GENERATION Agfa Healthcare N.V., Aug 5, 2011 |