The Recall Desk

FDA (Devices) recall action 89702

Draeger Medical, Inc. recalled 2 products on 2022-04-13

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2022-04-13
Critical
0
Units
—

Why these products were recalled

Cybersecurity Improvement Action-not equipped against potential cyber security threats

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Devices)··2022-04-13

    Draeger Babylog VN500 Ventilators Recalled for Cybersecurity Vulnerability

    Draeger Medical is recalling Babylog VN500 ventilators for neonatal and pediatric patients due to cybersecurity vulnerabilities. The devices are not equipped against potential cyber threats.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-04-13

    Draeger Evita V500 Ventilator Cybersecurity Vulnerability Affects Patient Safety

    Draeger Medical is recalling Evita V500 ventilators due to cybersecurity vulnerabilities that could potentially compromise device functionality. Affected units require software remediation.

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