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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00612-1
Product Name/Description	Artis systems with SW version VC14J (X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) Catalogue/Lot number – 10094137, 10094135, 10094141, 10094139, 10280959 with software version VC14J ARTG Number: 102177
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/07/2015
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	Artis system has an X-ray locking function that prevents any accidental release of radiation. If the systems enters "Bypass Fluoro" mode while the X-ray locking function is active a system error can occur which makes it impossible to exit the locking function without restarting the system or resolving the cause of the "Bypass Fluoro". In the situation described, no radiation is possible and no fluoroscopic images can be acquired.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is developing a software patch to ensure that the Artis system automatically unlocks the radiation release in "Bypass Flouro" mode. This will ensure that imaging is possible in all cases. This action has been closed-out on 22/08/2016.
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