Device recall

Z-2262-2020: Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s…

FDA device recall · Class II · Ventana Medical Systems Inc

Key facts

Recall number (Z-number) Z-2262-2020
Recall event 85526
Product Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in
Product code KPA
Recalling firm Ventana Medical Systems Inc
Recall class Class II
Status Completed
FEI number 1000125183

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)