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U.S. Department of Health and Human Services

Class 2 Device Recall Draeger

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  Class 2 Device Recall Draeger see related information
Date Initiated by Firm September 10, 2021
Create Date October 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-0109-2022
Recall Event ID 88635
510(K)Number K093632  
Product Classification Ventilator, continuous, facility use - Product Code CBK
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
Code Information Software 2.51 and Lower
Recalling Firm/
Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact SAME
Manufacturer 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
FDA Determined
Cause 2
Software design
Action Drager issued Urgent Medical Device Recall letter on 9/10/21 via FedEx with tracking (confirmation of delivery). Letter states reason for recall, health risk and action to take: The release of a corrected software is expected to be available in Q4 of 2021. Once the software is available, your local Dr¿ger Service representative will contact you to arrange a date for the software update to be performed free of charge. According to our records, at least one of the mentioned affected devices has been shipped to your facility. Please ensure that all users of the above-mentioned products and other concerned persons within your organization are made aware of this Urgent Medical Device Recall Notice. If you have provided the products to third parties, please forward a copy of this information. Please keep this information at least until the corrective measure has been completed. Please also complete and return the attached Customer Acknowledgment Card to confirm to us that you have received this information. If you have any questions regarding the operation of your Evita V500 or Babylog VN500, please contact Dr¿ger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2, then 1).
Quantity in Commerce 2,169 units
Distribution US Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = DRAGER MEDICAL AG & CO. KGAA