Hitachi Healthcare Americas Corp Informatics Division: Medical Device Recall in 2018 - (Recall #: Z-2992-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

VidiStar(TM) PACS & DICOM Viewer Software system

Product Classification:

Class II

Date Initiated: August 28, 2018

Date Posted: September 12, 2018

Recall Number: Z-2992-2018

Event ID: 80896

Reason for Recall:

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.

Status: Terminated

Product Quantity: 12 units

Code Information:

versions 3.10.5 and 3.10.6

Distribution Pattern:

SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA

Voluntary or Mandated:

Voluntary: Firm initiated