GE Healthcare, LLC GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Avance CS2 and Avance CS2 Pro - GTIN 00840682102322, all serial numbers, Aisys CS2 - GTIN 00840682102292, all serial numbers.
Products Sold
Avance CS2 and Avance CS2 Pro - GTIN 00840682102322, all serial numbers; Aisys CS2 - GTIN 00840682102292, all serial numbers.
GE Healthcare, LLC is recalling GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anes due to 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 ca. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, CT, FL, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MO, MT, NE, NV, NY, NC, OH, PA, SC, TN, TX, VA, WV
Page updated: Jan 10, 2026