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U.S. Department of Health and Human Services

Class 1 Device Recall Critical Car Ventilator

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  Class 1 Device Recall Critical Car Ventilator see related information
Date Initiated by Firm December 01, 2015
Date Posted December 23, 2015
Recall Status1 Terminated 3 on April 03, 2020
Recall Number Z-0436-2016
Recall Event ID 72754
510(K)Number K093633  K093632  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator.

Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
Code Information Catalog numbers: 8416400/8417400 distributed June 2011 October 2015.
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact
215-721-5400
Manufacturer Reason
for Recall		 The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm in the current software. Devices used for patient transport will be a priority.
FDA Determined
Cause 2		 Software design
Action Draeger Medical, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated November 2015 to all affected consignees. The letter identified the product, problem, and actions to be taken by the customers. The Battery Charging Software will be updated and, if necessary, the batteries replaced in all affected devices Free of Charge.
Quantity in Commerce 2422
Distribution US Nationwide-including DC and PR, and the states of AK; AR; AZ; CA; CO; CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD; TN; TX; UT; VA; VT; WA; WI; and WV.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = Draegerwerk AG & Co. KGaA
510(K)s with Product Code = CBK and Original Applicant = DRAGER MEDICAL AG & CO. KGAA
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