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U.S. Department of Health and Human Services

Class 2 Device Recall Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems

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 Class 2 Recall
Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems
see related information
Date Posted June 03, 2013
Recall Status1 Terminated on March 12, 2014
Recall Number Z-1443-2013
Recall Event ID 65164
Premarket Notification
510(K) Numbers
K090892  K110213  K112722  K122445  K123125 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.
Code Information Canisters with date code of 02-2013 (Feb 2013)
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems. Reusable CO2 absorbent canisters accessories may not seal properly.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter April 30, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Fax back form was included with the letter requesting the consignees to complete and return.
Quantity in Commerce 800
Distribution Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, CT, ID, MK, MI, NJ, NY, OH, TN, TX, and VA, and the countries of INDIA, AUSTRALIA, BAHRAIN, BANGLADESH, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDONESIA, IRAQ,ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA,LEBANON, MALAYSIA, MEXICO, NETHERLAND,NEW ZEALAND, OMAN, PARAGUAY, PERU., PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, THAILAND, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, and VIET NAM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DATEX-OHMEDA
510(K)s with Product Code = BSZ and Original Applicant = DATEX-OHMEDA, INC.
510(K)s with Product Code = BSZ and Original Applicant = GE HEALTHCARE FINLAND OY
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