Class 2 Device Recall GE Healthcare Avance and Aisys

• Date Initiated by Firm: May 27, 2022
• Create Date: July 20, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1427-2022
• Recall Event ID: 90422
• 510(K)Number: K172045
• Product Classification: Gas-machine, anesthesia - Product Code BSZ
• Product: GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
• Code Information: Avance CS2 and Avance CS2 Pro - GTIN 00840682102322, all serial numbers; Aisys CS2 - GTIN 00840682102292, all serial numbers.
• 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: The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.
• FDA Determined Cause: Process control
• Action: The recalling firm issued letters dated 5/27/2022 via traceable means on 5/27/2022 which were addressed to the Director of Respiratory, Chief of Anesthesia, Health Care Administrator/Risk Manager, and Director of Biomedical/Clinical Engineering. The letter is flagged that the consignee needs to ensure all potential users in the facility are made aware of this safety notification and recommended actions. The notification informs the consignees of the affected devices, the safety issue, and actions to be taken. The actions notified the consignee they can continue to use the anesthesia system by following instructions listed in the letter. The instructions were to inspect the anesthesia system for cracks at the rear of the base as depicted in the diagram and photograph, and if no cracks are observed, they can continue to use the anesthesia system. If a crack at the rear is observed, they can continue to use the system under the following conditions: Limit the movement of the system using care on uneven flooring/threshold and ensure the floor is clear of obstacles (cables, power cords, etc.); and do not exceed the recommended weight limit for equipment mounted or supported by the anesthesia system. A Medical Device Notification Acknowledgement Response form was to be completed and returned within 30 days of receipt to acknowledge receipt and understanding of the notification. The letter informs the consignee that the recalling firm will inspect all affected devices at no cost and that a firm representative will contact the consignee to arrange for the correction.
• Quantity in Commerce: 667 devices
• Distribution: Distribution was made to AZ, CA, CO, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MT, NC, NE, NV, NY, OH, PA, SC, TN, TX, VA, and WV. There was also military distribution but no government distribution. Foreign distribution was made to Australia, Canada, China, Estonia, Finland, France, Germany, Greece, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Korea, Malaysia, New Zealand, Philippines, Romania, Russia, Saudi Arabia, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
• 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.