FDA-Device2022-04-13Class II

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

Draeger Medical, Inc.
Hazard

Cybersecurity Improvement Action-not equipped against potential cyber security threats

Sold states
US Nationwide
Affected count
24,337 (10,728 units US)
Manufactured in
3135 Quarry Rd, Telford, PA, United States
Products
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400

Official notice

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

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