Artis zee Systems with generator A100Plus or Artis zeego Systems with software version VC21B. (fluoroscopic angiographic x-ray systems) 의 리콜

Recall

RC-2016-RN-00375-1

Class II

2016-03-31

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00375-1

The manufacturer, through post market surveillance, has identified the following problems with the affected devices:a) in artis zeego systems, angulations in the vicinity of the c-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. b) in artis systems with a100plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the x-ray tube) can result in the failure of a module in the high-voltage generator, which can lead to system non-availability.The reported issues can cause an ongoing procedure to be terminated.

Siemens service organisation will contact the affected customers to arrange for the installation of a software update, which will eliminate the reported problems.