FDA Medical Device Recalls (openFDA)
Hitachi Healthcare Americas Corp Informatics Division: VidiStar(TM) PACS & DICOM Viewer Software system
- Recall number
- Z-2992-2018
- Recalling firm
- Hitachi Healthcare Americas Corp Informatics Division
- Product
- VidiStar(TM) PACS & DICOM Viewer Software system
- Status
- Terminated
- Initiated
- 2018-08-28
- Posted
- not on file
- Terminated
- 2021-02-11
- Reason
- The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study.
- Root cause
- Software in the Use Environment
- Action
- The firm initiated the recall by email on 08/28/2018. The firm will be removing the 3rd party software from the interface and replacing it with new software and notify the affected customers when the action is completed.
- Quantity
- 12 units
- Distribution
- SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA
- Lot, serial or model codes
- versions 3.10.5 and 3.10.6
- 510(k) numbers
- ["K083910"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3019837913
- Firm city
- Greenville
- Firm state
- SC
- Firm country
- not on file
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