Date Initiated by Firm |
February 04, 2016 |
Date Posted |
February 25, 2016 |
Recall Status1 |
Terminated 3 on April 01, 2020 |
Recall Number |
Z-0827-2016 |
Recall Event ID |
73241 |
510(K)Number |
K093633 K093632
|
Product Classification |
Ventilator, continuous, facility use - Product Code CBK
|
Product |
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation. |
Code Information |
Catalog #s 8416400 and 8417400 |
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 battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.
|
FDA Determined Cause 2 |
Software design |
Action |
Draeger Medical, Inc. will send an Urgent Medical Device Recall Letter to consignees in a method that confirms delivery. For consignees that have received new devices with firmware version 1.50 (127 devices) or through device updates (644 devices; reference Recall Z-0436-2016), those devices will be downgraded to firmware version 1.49 and the batteries replaced. Batteries will continue to be replaced for all consignees every six months until a final solution is available. |
Quantity in Commerce |
2553 |
Distribution |
US Nationwide Distribution including Puerto Rico. |
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
|