Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (Fluoroscopic X-Ray System) 의 안전성 경고

Safety alert

2014-02-07

2014-02-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140207b.html

Medical device safety alert: ge healthcare precision 500d and proteus xr/a with wireless digital radiography option (fluoroscopic x-ray system) the australia therapeutic goods administration (tga) posted a medical device safety alert concerning precision 500d and proteus xr/a with wireless digital radiography option manufactured by ge healthcare. according to the manufacturer, there is an intermittent problem that when a large number of patient examinations are retrieved from the his/ris system, the examinations when displayed on the wdr1 are not properly displayed. if the user continues to attempt to select one of the examinations when this issue has occurred, the system will update the screen and in doing so, potentially select a different examination or patient. if the user does not notice this change and continues to perform the examination, the images will be placed in the incorrect patient file. the manufacturer is providing work around instructions for users to follow when using the wdr1 based systems for examinations. users should pay close attention to the patient examination/entry selected from the worklist prior to selecting the start exam button to ensure the system did not update and select an incorrect examination. the manufacturer is also providing a software upgrade as a permanent fix. for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00121-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 07 february 2014.