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U.S. Department of Health and Human Services

Class 3 Device Recall DatexOhmeda Cardiocap/5

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  Class 3 Device Recall DatexOhmeda Cardiocap/5 see related information
Date Initiated by Firm October 17, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 15, 2005
Recall Number Z-0143-04
Recall Event ID 27599
510(K)Number K992323  K012837  
Product Classification Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) - Product Code MHX
Product Datex-Ohmeda Cardiocap/5 Patient Monitors
Code Information The monitors in the serial number range FBWF00725 through FBWF03055 and FBWG00001 through FBWG02015 could be affected by the problem if they are mounted on the optional mounting stands for the product. The consignees notified of the field correction had purchased both the monitors and the stands.
Recalling Firm/
Manufacturer		 Datex-Ohmeda Inc
One Ohmeda Dr. Box 7550
Madison WI 53707
For Additional Information Contact Dale Thanig
608-221-1551 Ext. 3545
Manufacturer Reason
for Recall		 Datex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.
FDA Determined
Cause 2		 Other
Action Recall letters dated October 15, 2003 were sent to the consignees on 10/17/03. The letters request that the consignees order service kits to correct the units and use the kits to make the corrections of the devices.
Quantity in Commerce 875 units
Distribution The monitors were shipped to consignees located nationwide in the United States and to foreign consignees located 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 = MHX and Original Applicant = DATEX-OHMEDA
510(K)s with Product Code = MHX and Original Applicant = DATEX-OHMEDA, INC.
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