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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00281-2
Product Name/Description e.cam system
(Nuclear medicine gamma camera system )

Catalogue Number: 10151532

ARTG Number: 186317
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 10/03/2016
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens has identified that refurbished e.cam systems have been delivered to users without the full user documentation. The training provided to users provides the necessary cautions and warnings; however these manuals provide additional instructions and reference materials necessary for the safe and proper operation of the systems.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is providing users with the full instruction manual.
This action has been closed out on 20/08/2018.
Contact Information 1800 310 300 - Siemens Technical Support Centre