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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00893-1
Product Name/Description Mammomat Inspiration (diagnostic mammography X-Ray system)

ARTG Number: 144223
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/11/2012
Responsible Entity Siemens Ltd
Reason/Issue An addendum of the operating manual has been released to provide more detailed description about the emergency release of the compression unit in case of system error or a power failure.
Recall Action Recall for Product Correction
Recall Action Instructions The sponsor is providing an update to the Instructions for Use (IFU).
Contact Information 1800 310 300 - Siemens Regulatory Affairs