FDA recall Z-0870-2022

Draeger Medical, Inc. · Class II · device

Product

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

Reason for recall

Cybersecurity Improvement Action-not equipped against potential cyber security threats

Distribution

US Nationwide

Key facts

Status: Terminated
Initiation date: 2022-02-14
Report date: 2022-04-13
Termination date: 2025-01-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0870-2022