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Class 2 Device Recall Dfend and Dfend water trap |
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Date Initiated by Firm |
April 24, 2015 |
Date Posted |
May 28, 2015 |
Recall Status1 |
Terminated 3 on September 07, 2016 |
Recall Number |
Z-1680-2015 |
Recall Event ID |
71044 |
510(K)Number |
K051092
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Product Classification |
Analyzer, gas, oxygen, gaseous-phase - Product Code CCL
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Product |
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors.
Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and D-fend+ water traps are used with Compact gas module E-C(Ai)O(V)(X) and CardioCap/5 monitors. The Datex-Ohmeda S/5 Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patients respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N2O+O2 mixtures. The device is indicated for use by qualified medical personnel only.
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Code Information |
p/n 876446-HEL Lot numbers: J9964985, J10201698, J10258248, J10284871, J10284872, J10344108. p/n 881319-HEL Lot numbers: J9906966, J9965152, J10258251, J10300071. |
Recalling Firm/ Manufacturer |
GE Healthcare 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact |
GE Healthcare Service 800-437-1171
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Manufacturer Reason for Recall |
A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. This water trap occlusion could cause a loss of respiratory airway gas monitoring.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref#36111 dated April 24, 2015. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, & Director of Biomedical Engineering, The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. A confirmation form is asked to be returned and GE will replace all affected product. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
Quantity in Commerce |
5,018 (US = 2,948 / OUS = 2,070) |
Distribution |
Worldwide Distribution - US Nationwide including Washington DC, Puerto Rico. and the countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic , Egypt, Estonia, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guernsey , Guernsey , Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Korea (Republic of), Kuwait, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand , Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam, |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = CCL and Original Applicant = GE HEALTHCARE
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