Device recall

Z-0870-2022: Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the…

FDA device recall · Class II · Draeger Medical, Inc.

Key facts

Recall number (Z-number) Z-0870-2022
Recall event 89702
Product Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Product code CBK
Recalling firm Draeger Medical, Inc.
Recall class Class II
Status Terminated
Termination date Jan 7, 2025
510(k) numbers K093633
FEI number 2517967

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)