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U.S. Department of Health and Human Services

Class 1 Device Recall GE Healthcare Aisys and Avance

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  Class 1 Device Recall GE Healthcare Aisys and Avance see related information
Date Initiated by Firm June 01, 2022
Create Date July 19, 2022
Recall Status1 Open3, Classified
Recall Number Z-1389-2022
Recall Event ID 90424
510(K)Number K172045  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
Code Information Aisys CS2 - GTIN 00840682102292 Serial numbers starting with APWA: 00101 through 00176, 00185 through 00697, 00700 through 00763, 00768 through 01013, 01016 through 01216, 01218 through 01223, 01225 through 01596, 01601 through 01683, 01685 through 01805, 01808 through 01960, 01964 through 01999, 02003 through 02021, 02026 through 02168, 02175, 02182 through 02308, 02311 through 02361, 02376 through 02405, 02424 through 02429, 02450 through 02456, 02519 through 02531, 02533 through 02539. Serial numbers starting with APWB: 00101 through 00151, 00154, 00155, 00162, 00163, 00169 through 00199, 00201 through 00336, 00338 through 00373, 00378 through 00644, 00647 through 00684, 00686 through 00689, 00691 through 00743, 00746 through 00750, 00754 through 00756, 00770 through 00818, 00823 through 00828, 00838 through 00842, 00905 through 00931, 00944 through 00952. Serial numbers starting with APWZ: 03034 through 03037, 03053 through 03056, 03060, 03062 through 03066, 03071 through 03075, 03164 through 03171, 03311 through 03314, 03319, 03320, 03381 through 03415, 03420 through 03422. Avance CS2 and Avance CS2 Pro - 00840682102322, Serial numbers starting with APKA: 00101 through 00105, 00107 through 00165, 00167 through 00176, 00178 through 00218, 00220 through 00767, 00776 through 00836, 00838 through 01081, 01084 through 01150, 01152 through 01467, 01469 through 01532, 01537 through 01541, 01543 through 01809, 01811 through 01894, 01921 through 01961, 01965 through 01985, 02009 through 02013, 02016 through 02029. Serial numbers starting with APKB: 00101 through 00108, 00110 through 00121, 00123 through 00265, 00269 through 00293, 00295 through 00417, 00422 through 00438, 00441 through 00452, 00462, 00464 through 00473, 00478, 00480 through 00487, 00490 through 00492, 00495 through 00513, 00515 through 00517. Serial numbers APKZ00247, 00506, 02331, 02336, 02337, 02510 through 02569.
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 There is a potential reversal of the O2 and air cylinder pressure transducer connections.
FDA Determined
Cause 2		 Employee error
Action The recalling firm issued letters beginning 6/1/2022 via traceable means to the the Chief of Anesthesia, Director of Biomedical/Clinical Engineering, and Health Care Administrator/Risk Manager at their consignee locations. The letter was flagged that consignees should ensure all potential users in their facility are made aware of this safety notification and the recommended actions. The letter provided the affected products, safety issue, and actions to be taken. The customer was informed they could continue to use the anesthesia system by following the instructions provided in the letter prior to use. A Medical Device Notification Acknowledgement Response form was enclosed to acknowledge receipt and understanding of the notice. The consignee was to record their anesthesia system serial number, whether it passed or failed the test, and the date of the test. The response form was supposed to be completed and returned no later than 30 days from receipt.
Quantity in Commerce 5,372 devices
Distribution Worldwide Distribution. US nationwide, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kenya, Korea, Kuwait, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = Datex-Ohmeda, Inc.
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