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 number

Z-1427-2022

Recalling firm

GE Healthcare, LLC

Product

GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.

Status

Open, Classified

Initiated

2022-05-27

Posted

not on file

Terminated

not on file

Reason

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.

Root 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

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.

Lot, serial or model codes

Avance CS2 and Avance CS2 Pro - GTIN 00840682102322, all serial numbers; Aisys CS2 - GTIN 00840682102292, all serial numbers.

510(k) numbers

["K172045"]

PMA numbers

not on file

Product code

BSZ

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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