Device recall

Z-2521-2023: ZVU Functional GI Software, REF: ZVU-3

FDA device recall · Class III · Diversatek Healthcare

Key facts

Recall number (Z-number) Z-2521-2023
Recall event 92854
Product ZVU Functional GI Software, REF: ZVU-3
Product code FFX
Recalling firm Diversatek Healthcare
Recall class Class III
Status Open, Classified
510(k) numbers K012232
FEI number 2023374

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

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