Z-1427-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- May 27, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 667 devices
Product Description
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
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.
Distribution Pattern
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.
Code Information
Avance CS2 and Avance CS2 Pro - GTIN 00840682102322, all serial numbers; Aisys CS2 - GTIN 00840682102292, all serial numbers.