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U.S. Department of Health and Human Services

Class 1 Device Recall Critical Care Ventilator

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 Class 1 Device Recall Critical Care Ventilator see related information
Date Posted February 25, 2016
Recall Status1 Open
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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