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U.S. Department of Health and Human Services

Class 2 Device Recall S/5 Aneshesia Delivery Unit

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 Class 2 Device Recall S/5 Aneshesia Delivery Unitsee related information
Date Initiated by FirmNovember 16, 2005
Date PostedMay 09, 2006
Recall Status1 Terminated 3 on January 23, 2007
Recall NumberZ-0857-06
Recall Event ID 34050
510(K)NumberK973985 
Product Classification Aneshesia Delivery Unit - Product Code BSZ
ProductDatex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)
Code Information 6025108 thru 6025111, 6025114 thru 6025117, 6025119, 6025120, 6025122 thru 6025128, 6025130 thru 6025132, 6025134, 6025136, 6025137, 6035737, 6035738, 6035740 thru 6035745, 6035747, 6035751, 6035757, 6035758, 6035760, 6035762, 6035765, 6035772 thru 6035774, 6035784, 6048756 thru 6048761, 6048764, 6048847, 6048849, 6048853 thru 6048856 and 40300736
FEI Number 2183066
Recalling Firm/
Manufacturer		 GE Healthcare
3030 Ohmeda Drive
PO Box 7550, zip 53707-7550
Madison WI 53718
Manufacturer Reason
for Recall		Alarm sound-It is possible that the audible alarms from the speaker from the Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) machine may dampen or disappear as a result of normal handling of the anesthesia machine. Visual alarms on the ADU are unaffected by this condition. The dampening or absence of audible alarms on the ADU may result in a delay in treatment.
FDA Determined
Cause 2		Other
ActionCustomers were sent a letter dated November 16, 2005, informing them of the possible alarm failure and giving them short term and long term solutions. Short term, clinicians are to: 1) check the audio alarm prior to use; and 2) use the ADU in conjunction with functioning anesthetic agent monitor. In the long term a GE Healthcare representative will contact the facility and schedule a visit to implement the corrective action at no charge.
Quantity in Commerce113---(USA-61--International-52)
DistributionWorldwide---USA-States of AZ, CA, IA, MI, TX, and WI ----International- Australia, Austria, Belgium, Finland, Germany, Israel, Italy, Jordan, Malaysia, Netherlands, Norway, Portugal, Slovakia, South Africa, and Turkey.
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 = BSZ
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