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U.S. Department of Health and Human Services

Class 1 Device Recall Aestiva/5 7900 SmartVent

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  Class 1 Device Recall Aestiva/5 7900 SmartVent see related information
Date Initiated by Firm April 10, 2012
Date Posted June 17, 2012
Recall Status1 Terminated 3 on July 09, 2012
Recall Number Z-1787-2012
Recall Event ID 61639
510(K)Number K023366  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
Code Information Serial Number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This m
FDA Determined
Cause 2		 Process control
Action GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 10, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact GE Healthcare Customer or Technical Support at 800-345-2700 for questions regarding this notification.
Quantity in Commerce 8
Distribution Nationwide Distribution - including the states of AL, FL, GA, MO, and VA.
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 = DATEX-OHMEDA, INC.
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