Class 2 Device Recall GE DatexOhmeda ADU Carestation

• Date Initiated by Firm: October 30, 2008
• Date Posted: July 30, 2009
• Recall Status: Terminated on May 17, 2012
• Recall Number: Z-1633-2009
• Recall Event ID: 50800
• 510(K)Number: K050676 K042154 K973985
• Product Classification: Gas-Machine for Anesthesia - Product Code BSZ
• Product: GE Datex-Ohmeda ADU Carestation; ; Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients.
• Code Information: 40010266 40007614 40162385 40102538 40102539 40102540 40103216 40094168 40094169 40177773 40177774 40010303 40016231 40111765 40111766 40059761 40041764 400497962 40016293 40078704 40078752 40117250 40094153 40094154 40094156 40094158 40094160 40094162 40132088 40122596 40122597 40122598 40122630 40163531 40167362 40300005 40163526 40163527 40163528 40163529 40022236 40022261 40022271 40022274 40075058 40075059 40075064 40075091 40124797 40221729 40221730 40221731 40221732 40221733 40221734 40221735 40143446 40143449 40143450 40145288 40145289 40145290 6035764 40113769 40013565 40015856 40150842 40016222 40016223 40117249 40170266 40178071 40049737 40001801 40003091 40003092 40059753 40059754 40059756 40059757 40059758 40224004 40224005 40080038 40110693 40110694 40110695 40110696 40110697 40110698 40110699 40102544 6017408 6017409 6017410 6048828 6048838 6048839 6048840 6048848 6050870 6067632 6067633 6067635 6067643 6067644 6085929 6125598 6125599 6125600 6125600 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• Recalling Firm/ Manufacturer: GE Healthcare; 9900 Innovation Drive; Wauwatosa WI 53226
• Manufacturer Reason for Recall: GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety.
• FDA Determined Cause: Other
• Action: A GE Healthcare "Urgent Medical Device Correction" letter was sent to consignees on 1/16/09. The letter was addressed to Health Care Administrator, Chief of Anesthesia and Director of Clinical Engineering. The letter described the Safety Issue; Affected Product Details; Safety Instructions, which include clinical personnel being properly trained on the correct connections of breathing circuit tubing and proper execution of System Checkout according to the ADU URMs; Product Correction and Contact Information.
• Quantity in Commerce: 925
• Distribution: USA including states of AL, AK, AZ, AR, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, and WI and countries of Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia & Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, England, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Isle of Man (UK), Israel, Italy, Japan, Jordan, Kazahkstan, Kuwait, Latin America, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Yemen.
• 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 = BSZ and Original Applicant = DATEX-ENGSTROM, INC.; 510(K)s with Product Code = BSZ and Original Applicant = DATEX-OHMEDA, INC.