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U.S. Department of Health and Human Services

Class 2 Device Recall DatexOhmeda

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 Class 2 Device Recall DatexOhmedasee related information
Date Initiated by FirmFebruary 03, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on November 17, 2005
Recall NumberZ-0545-04
Recall Event ID 28182
510(K)NumberK973985 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
ProductDatex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the machine. There were no design or feature and function modifications when the name change occurred.)
Code Information The affected units in the United States have serial numbers between 40013635 and 40162379. 
Recalling Firm/
Manufacturer		 Datex-Ohmeda Inc
One Ohmeda Dr. Box 7550
Madison WI 53707
For Additional Information ContactMr. William Exner
608-221-1551 Ext. 3115
Manufacturer Reason
for Recall		Anesthetic agents could be delivered at concentrations above the concentration set on the S/5 and AS/3 Anesthesia Delivery Units (ADU) having serial numbers within a specified range.
FDA Determined
Cause 2		Other
ActionRecall letters dated February 03, 2004 stated that a firm representative would contact the consignee to schedule a visit to replace software and hardware to correct the problem.
Quantity in Commerce1617 units in the United States
DistributionThe product was distributed nationwide to hospitals in the Unites States.
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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