FDA Medical Device Recalls (openFDA)
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 within the system and across computer networks.
- Recall number
- Z-0101-2019
- Recalling firm
- Agfa Healthcare NV
- Product
- 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 within the system and across computer networks.
- Status
- Terminated
- Initiated
- 2018-08-03
- Posted
- not on file
- Terminated
- 2020-04-03
- 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 Area. The images show the date the study was performed. 2. We recommend that an upgrade be applied to correct this issue. Refer to the table for affected versions and associated correction. An Agfa HealthCare service representative will contact you to arrange for a date to deploy the appropriate upgrade at your facility. Please distribute this information within your facility to all those who need to be aware of it. If you have any questions about this matter, please contact your local Agfa HealthCare organization 1-866-599-3868 and please reference Problem Record PRB0056200 and Vigilance Record VR0000568.
- Quantity
- 17
- Distribution
- US distribution to states of: CA, FL, IN, LA, MN, PA, SC, TX, VA, and Puerto Rico and internationally to: Canada.
- Lot, serial or model codes
- Versions 8.0.0, 8.0.0 SP1 & 8.0.0 SP2., 8.0.1, 8.0.1 SP1, 8.0.1 SP2, 8.0.1 SP3, 8.0.1 SP4, 8.0.1 SP5, 8.0.1 SP6., 8.1, 8.1 SP1, 8.1 SP2.
- 510(k) numbers
- ["K111945"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3009471886
- Firm city
- Mortsel
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28