Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900

Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.

On June 24, 2026, the firm began issuing "Urgent Medical Device Correction" letters via FedEx to customers at the Risk Manager level. Customers were informed that according to the Instructions for Use, this indication signifies that concentration levels are below detectable limits, serving as confirmation that no agent is present: **/gas analyzer has no information to display Customers were given recommended precautions to identify and mitigate the issue, such as confirming that the anesthetic agent is being delivered after activating the vaporizer, and continuously monitoring end-tidal anesthetic agent concentration and patient vital signs to ensure adequate anesthesia is maintained. If delivery is not confirmed, end case and start up again. The firm has developed a software update, version 4.8.7, which will improve stability during case start-up, thereby reducing the risk of no anesthetic agent delivery events. Customers are instructed to identify all affected product in their inventory and notify any individuals within their organization or where the affected devices have been transferred. Customers should contact their local Getinge representative to assist with downloading the updated software.