Draeger Medical, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0108-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400

Product Classification:

Class II

Date Initiated: September 10, 2021

Date Posted: October 20, 2021

Recall Number: Z-0108-2022

Event ID: 88635

Reason for Recall:

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds

Status: Ongoing

Product Quantity: 6,797 units

Code Information:

Software 2.51 and Lower

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated