Class 1 Device Recall Aisys CS2 with Et Control

• Date Initiated by Firm: July 12, 2024
• Date Posted: October 18, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0083-2025
• Recall Event ID: 95045
• PMA Number: P210018
• Product Classification: Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents - Product Code QSF
• Product: Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
• Code Information: GTIN: 00195278588128. Model Number: 1011-9055-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected.
• Recalling Firm/ Manufacturer: Datex-Ohmeda, Inc.; 3030 Ohmeda Dr; Madison WI 53718-6704
• For Additional Information Contact: GE Healthcare Service; 800-437-1171
• Manufacturer Reason for Recall: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
• FDA Determined Cause: Device Design
• Action: GE Healthcare notified consignees on about 07/12/2024 via letter. Consignees were instructed to ensure all potential users complete the Preoperative Checkout procedure in its entirety, as detailed in the URM, make sure that the breathing circuit is correctly connected, only connect an auxiliary manual breathing circuit to the ACGO port, place the included addendum with the URM and inspect all potentially affected devices for the presence of covers applied to the ACGO Port and ACGO Switch. Additionally, customers were requested to complete and return the response form.
• Quantity in Commerce: 92 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = QSF