Draeger Medical, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0870-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400

Product Classification:

Class II

Date Initiated: February 14, 2022

Date Posted: April 13, 2022

Recall Number: Z-0870-2022

Event ID: 89702

Reason for Recall:

Cybersecurity Improvement Action-not equipped against potential cyber security threats

Status: Terminated

Product Quantity: 24,337 (10,728 units US)

Code Information:

All Lots/Serial Numbers. UDI: 04048675042266

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated