Recall Z-0109-2022— Draeger Medical, Inc.

Name: FDA recall Z-0109-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-10

Class II · Ongoing

Class II FDA medical device recall by Draeger Medical, Inc., initiated 2021-09-10. It names one FDA 510(k) clearance: K093632. Product: Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of 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: Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds.

Recalling firm: Draeger Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-09-10
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 Installed CO2 Measurement Option-intended for the ventilation of 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

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds

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