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U.S. Department of Health and Human Services

Class 1 Device Recall PS500 of an IACS Workstation Critical Care (Evita Infinity V500)

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  Class 1 Device Recall PS500 of an IACS Workstation Critical Care (Evita Infinity V500) see related information
Date Initiated by Firm July 13, 2015
Date Posted August 14, 2015
Recall Status1 Terminated 3 on March 01, 2017
Recall Number Z-2343-2015
Recall Event ID 71702
510(K)Number K093633  K093632  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Code Information Catalog Number(s): 8416400, 8417400
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Customer Support
215-721-5400
Manufacturer Reason
for Recall		 The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Draeger Medical, Inc. sent an Urgent Medical Device Recall Letter, dated July 2015, to end users to inform them of the issue and provide interim instructions to avoid the associated risk to patients. All PS500 batteries will be exchanged free of charge.
Quantity in Commerce 2081
Distribution Nationwide Distribution.
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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