Class 2 Device Recall Aestiva 7900

• Date Initiated by Firm: August 02, 2021
• Create Date: September 30, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2596-2021
• Recall Event ID: 88400
• 510(K)Number: K172045
• Product Classification: Gas-machine, anesthesia - Product Code BSZ
• Product: Flow sensors that may be installed in the following GEHC anesthesia machines:; ; (1) Aestiva MRI, GTIN 0080682102339;; (2) Aestiva 7900;; (3) Aestiva 7100;; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100);; (5) S/5 Aespire 7900;; (6) Aespire View;; (7) Avance;; (8) Avance CS2, GTIN 00840682102292;; (9) Aisys;; (10) Aisys CS2, GTIN 00840682102322;; (11) Amingo;; (12) 9100 NXT Config, Aelite NXT;; (13) Protiva 7100
• Code Information: The flow sensors built prior to June 2021 that are installed in the devices/anesthesia machines.
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 800-437-1171
• Manufacturer Reason for Recall: The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm issued Urgent Medical Device Correction letters on 8/2/2021 via FedEx explaining the safety issue. This letter informs the customer of the issue and provides safety instructions, including requesting the consignee inspect all inventory of flow sensors. GE Healthcare will replace the flow sensors indicated on returned customer response forms, when applicable. The consignee will be responsible for replacing the flow sensor. The letter was sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, Health Care Administrator / Risk Manager
• Quantity in Commerce: Estimated 310,072 flow sensors
• Distribution: Distribution was nationwide, including PR. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote D'lvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Macedonia, Madagascar, Malaysia, Maldives, Mali, Malta, Mauritius, Mexico, Moldova, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom Uruguay, Venezuela, Vietnam, 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 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.