Z-0871-2022 Class II Terminated

Recalled by Draeger Medical, Inc. — Telford, PA

Recall Details

Product Type
Devices
Report Date
April 13, 2022
Initiation Date
February 14, 2022
Termination Date
January 7, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,687 (2,987 units US)

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

Reason for Recall

Cybersecurity Improvement Action-not equipped against potential cyber security threats

Distribution Pattern

US Nationwide

Code Information

All Lots/Serial Numbers. UDI: 04048675250418