Recall Z-0871-2022— Draeger Medical, Inc.

Name: FDA recall Z-0871-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-14

Class II · Terminated

Class II FDA medical device recall by Draeger Medical, Inc., initiated 2022-02-14, terminated 2025-01-07. It names one FDA 510(k) clearance: K093632. 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: Cybersecurity Improvement Action-not equipped against potential cyber security threats.

Recalling firm: Draeger Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-02-14
Terminated: 2025-01-07
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K093632 — INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CAREDrager Medical AG & Co. Kgaa·cleared 2010-04-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.