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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00623-1
Product Name/Description Biograph mCT systems running the VG40A or VG40B software
(Digital Imaging System)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/06/2013
Responsible Entity Siemens Ltd
Reason/Issue This recall action is an update to RC-2013-RN-00357-1.Siemens has identified that Biograph mCT systems running software VG40A or VG40B can experience intermittent aborting of CT or PET/CT scans during an examination, in addition to intermittent CT planning and image reconstruction failures. These issue are due to software errors.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is advising end users on how a check can be performed during the planning of the CT acquisitions and reconstructions, within a PET/CT protocol that could indicate that a problem is likely to occur. The problems will be addressed in the upcoming VG40C software release which is planned to be released within the next 2 months.
Contact Information 1800 310 300 - Siemens Technical Assistance