Device recall

Z-2913-2026: navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify…

FDA device recall · Class II · Ventana Medical Systems, Inc.

Key facts

Recall number (Z-number) Z-2913-2026
Recall event 98998
Product navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche…
Product code PSY
Recalling firm Ventana Medical Systems, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K232879, K242783
FEI number 1000125183

At a glance

  • 1–9 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)