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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00077-1
Product Name/Description Artis Zee Systems equipped with a card collimator

Artis Zee material numbers: 10094135, 10094137 and 10094141

Card collimator material numbers: 10092591, 10092593, 10092601, 10092631 and 10092632

ARTG Number: 102177
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 31/01/2013
Responsible Entity Siemens Ltd
Reason/Issue At the card collimators of these systems, a dislocation of the scatter radiation filter inside the card collimater may occur.

This recall action was carried out prior to approval of the recall strategy by the TGA.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is providing a replacement filter to fix the issue.
Contact Information 1800 310 300 - Siemens Regulatory Affairs