Device recall

Z-2992-2018: VidiStar(TM) PACS & DICOM Viewer Software system

FDA device recall · Class II · Hitachi Healthcare Americas Corp Informatics Division

Key facts

Recall number (Z-number) Z-2992-2018
Recall event 80896
Product VidiStar(TM) PACS & DICOM Viewer Software system
Product code DQK
Recalling firm Hitachi Healthcare Americas Corp Informatics Division
Recall class Class II
Status Terminated
Termination date Feb 11, 2021
510(k) numbers K083910
FEI number 3019837913

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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