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U.S. Department of Health and Human Services

Class 2 Device Recall DatexOhmeda Cardiocap

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  Class 2 Device Recall DatexOhmeda Cardiocap see related information
Date Initiated by Firm September 16, 2002
Date Posted March 05, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall Number Z-0611-03
Recall Event ID 25501
510(K)Number K012837  
Product Classification Oximeter, Ear - Product Code DPZ
Product Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option
Code Information All units with N-XOSAT SpO2 measurement option distributed prior to the recall. September 16, 2002
Recalling Firm/
3030 Ohmeda Dr. Box 7550
Madison WI 53707
Manufacturer Reason
for Recall
Falsely high blood oxygen saturation readings in some circumstances which could result in no alarm in a critical life-threatening situation.
FDA Determined
Cause 2
Action 'Medical Device Advisory Notice' letters dated September 16, 2002 were sent to the consignees, gave recommendations about alternative monitoring for certain patients, and stated that there would be a field correction to reduce the possibility of the problem.
Quantity in Commerce 85
Distribution Nationwide in the United States and worldwide.
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 = DPZ and Original Applicant = DATEX-OHMEDA