ICON P and ICON AP Autoperfusion Workstation Software Version 1.2 designated for use with E.Cam CT with Computerized Emission Systems 의 안전성 경고

Safety alert

556

2002-03-08

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

Under certain conditions, the above software may store the data in progress (gated data) instead of the cumulative data used in the last period (nongated). this will occur if the user processes the user to process a simple self perfusion study, and select the save composite option, saving the results of the current page instead of the entire process page. the manufacturer initiated a field correction by letter dated june 26, 2002.

Check that you have received the letter of correction dated June 26, 2002, Siemens self-infusion warning letter. Identify and isolate any affected product in your inventory. The intended use of the cardiac revision application is to evaluate the combined data of stress (gated or nongated) and rest. Saved data is stored in a composite file, which is used to view images within the cardiac review application. If the user chooses to revise only a single current set (gated), or user must choose the "save composite" option from the processing page, not from the results page. If your Auto Perfusion software version is 1.2, and has not been upgraded to version 1.3, always save it on the processing page, not on the results page, when processing a simple dataset. The manufacturer requests that you share this information with all other ICON users on your premises. For more information, contact the Siemens Service Center. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485