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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00079-1
Product Name/Description ACUSON S2000 Automated Breast Volume Scanner (ABVS)

ARTG Number: 137563
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 29/01/2013
Responsible Entity Siemens Ltd
Reason/Issue On some ACUSON S2000 ABVS systems, the edges on the inside of the transducer pod may not have been completely deburred to avoid sharp edges.
Recall Action Recall for Product Correction
Recall Action Instructions A Siemens Service Engineer will perform an onsite inspection to determine if burrs are present on your device. The service engineer will remove any burrs if present.
Contact Information 1800 310 300 - Siemens Regulatory Affairs