FDA-Device2022-07-27Class II
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
GE Healthcare, LLC
Hazard
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.
Sold states
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.
Affected count
667 devices
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1427-2022Don't want to check this manually?
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