Cios Alpha mobile C-arm x-ray system 의 리콜

Recall

RC-2015-RN-00818-1

Class II

2015-08-28

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00818-1

Siemens have received reports that under certain circumstances, when starting the system up or reconnecting the c-arm cable to the main unit, the error 5000/243 “no x-ray - fd re-initialises” may occur. the error refers to a potential hardware malfunction of the cios alpha c-arm x-ray system that may occur when starting the system up or reconnecting the c-arm cable to the main unit. when this occurs, the system will become inoperable until the affected part is replaced.

Siemens is planning to release a modification for the Cios Alpha mobile C-arm x-ray system that will resolve the above-mentioned potential malfunction. As soon as the modification is available, a Siemens service engineer will contact customers to schedule implementation of the modification for your system. Siemens is providing the following instructions to minimise the risk of this issue: · Ensure that the system is ready after the startup · Ensure that the error 5000/243 is not displayed, neither as message box nor in the FLC status bar (lower left side of the left monitor) · In general, avoid disconnecting and reconnecting the C-arm cable during or shortly before starting a procedure. This action has been closed-out on 31/08/2016.