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U.S. Department of Health and Human Services

Class 2 Device Recall DatexOhmeda Aestiva/5

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 Class 2 Device Recall DatexOhmeda Aestiva/5see related information
Date Initiated by FirmApril 16, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on November 14, 2005
Recall NumberZ-0969-04
Recall Event ID 28936
510(K)NumberK993410 
Product Classification Apparatus, Gas-Scavenging - Product Code CBN
ProductDatex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite.
Code Information Serial numbers AMTG00208, AMTG00212, AMTG00213, AMTG00216, AMTG00219, AMTG00220, AMTG00222, AMTH00113, AMTH00121, and AMTH00124
Recalling Firm/
Manufacturer		 Datex-Ohmeda Inc
One Ohmeda Dr. Box 7550
Madison WI 53707
For Additional Information ContactMr. Gary Muellenbach
800-345-2700 Ext. 3583
Manufacturer Reason
for Recall		Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.
FDA Determined
Cause 2		Other
ActionRecall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit.
Quantity in Commerce10 units
DistributionThe affected units were distributed nationwide in the United States and worldwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CBN
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