Safety Alert for Commercial Name: Anesthesia System and Anesthesia Equipment Technical Name: Anesthesia System Advance and Anesthesia Equipment Advance CS2 Registration Number ANVISA: 80071260227 Hazard Class: III Model Affected: Anesthesia System Advance and Anesthesia Equipment Advance CS2 Serial Numbers affected: All Anesthesia Systems Advance. Aespire systems are not affected.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

You can continue to use your Advance CS2 devices after removing the optional large tray insert if installed. The optional large tray insert can be removed from the device manually by any clinical user or authorized local personnel. No tools and or technical training are required to remove the large tray insert. Avance CS2 and Advance anesthesia devices with optional large insert tray insert (part number 1009-3260-000) are susceptible to the problem. The large tray insert accessory can also be used in the Aespire family of devices, but the Aespire devices are not susceptible to this problem. Inserting an optional small tray does not produce this problem. GE Healthcare requests clinical users who have received this device patch warning to destroy all large-tray inserts in their possession. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.