GE Healthcare Avance CS2 recall
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
Why was GE Healthcare Avance CS2 recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Avance CS2 and Avance CS2 Pro - GTIN 00840682102322, all serial numbers; Aisys CS2 - GTIN 00840682102292, all serial numbers.
- Product
- GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
- Recalling firm
- GE Healthcare, LLC
- 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.
- Recall date
- July 27, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)