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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 Recall
Aestiva/5 7900 SmartVent
see related information
Date Posted June 17, 2012
Recall Status1 Terminated on July 09, 2012
Recall Number Z-1787-2012
Recall Event ID 61639
Premarket Notification
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, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 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.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = DATEX-OHMEDA, INC.
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