Device recall

Z-2101-2018: Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity…

FDA device recall · Class II · GE Healthcare

Key facts

Recall number (Z-number) Z-2101-2018
Recall event 80159
Product Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or…
Product code LLZ
Recalling firm GE Healthcare
Recall class Class II
Status Terminated
Termination date Nov 2, 2023
510(k) numbers K123174
FEI number 3004526608

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

Browse all FDA device recalls (products)