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 | K093632 K093633 |
Product Classification |
Ventilator, continuous, facility use - Product Code CBK
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = CBK 510(K)s with Product Code = CBK
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