GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled 667 anesthesia systems across three models: the Avance CS2, Avance CS2 Pro, and Aisys CS2. These devices were distributed to 29 U.S. states, military facilities, and multiple countries worldwide. The recall addresses a safety hazard in which the base of the anesthesia system can develop a crack that may eventually fracture, causing the system to tip or become unstable.
If the anesthesia system tips or falls due to a fractured base, it could potentially injure people nearby. The affected devices include all serial numbers for the Avance CS2 and Avance CS2 Pro (GTIN 00840682102322) and all serial numbers for the Aisys CS2 (GTIN 00840682102292). The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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 Zeala Quantity: 667 devices Lot/code info: Avance CS2 and Avance CS2 Pro - GTIN 00840682102322, all serial numbers; Aisys CS2 - GTIN 00840682102292, all serial numbers.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.