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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01027-1
Product Name/Description Siemens AX System (Digital fluoroscopicc x-ray system) fitted with MAVIG PORTEGRA 2 System (Radiation protection system)

Part Numbers for the MAVIG PORTEGRA 2 System: 7721165, 4787714, 7559375, 10281150, 10281151, 10281152 and 10281153
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 10/10/2012
Responsible Entity Siemens Ltd
Reason/Issue A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems. The component would hold a pin in position in case that pin gets released and thus prevent system parts from becoming loose, leading to an adverse effect on the function and possibly becoming detached from the system.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is advising users that a technician will perform an update to the affected systems.
Contact Information 1800 310 300 - Siemens Regulatory Affairs