Device recall

Z-0118-2027: HexaVue Focus Integration System, a single, all-in-one system that handles…

FDA device recall · Class II · Steris Corporation

Key facts

Recall number (Z-number) Z-0118-2027
Recall event 99856
Product HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18
Product code FTA
Recalling firm Steris Corporation
Recall class Class II
Status Open, Classified
FEI number 1527821

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)