Draeger Medical, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0871-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 14, 2022

Date Posted: April 13, 2022

Recall Number: Z-0871-2022

Event ID: 89702

Reason for Recall:

Cybersecurity Improvement Action-not equipped against potential cyber security threats

Status: Terminated

Product Quantity: 13,687 (2,987 units US)

Code Information:

All Lots/Serial Numbers. UDI: 04048675250418

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated