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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00076-1
Product Name/Description Artis Zee/Zeego Systems equipped with A 100 plus generator (Fluoroscopic angiographic digital x-ray system)

System Material numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959

Generator Material number: 10563420
ARTG Number: 102177
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/02/2013
Responsible Entity Siemens Ltd
Reason/Issue Siemens has determined that the A 100 plus generator may fail during operation when equipped with the Artis Zee/Zeego system. The generator fails due to a tolerance problem in the power supply of the generator control.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens will be fitting affected systems with a modified board assembly which is able to cover larger tolerance deviations
Contact Information 1800 310 300 - Siemens Regulatory Affairs