FDA recall Z-0871-2022

Draeger Medical, Inc. · Class II · device

Product

Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400

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-0871-2022