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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00771-1
Product Name/Description	Specular Microscope SP-1P (non-invasive photographic microscope) ARTG Number: 131014
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/07/2014
Responsible Entity	Device Technologies Australia Pty Ltd
Reason/Issue	It has come to the attention of Topcon Corporation that during the analysis of large corneal endothelial cells captured by the “Specular Microscope SP-1P” the unit may provide higher than actual cell count. Topcon Corporation found that in some cases when an image with large corneal endothelial cells (approximate cell density 1,500 cells/mm2 or less) was analysed the cell density may be higher due to a smaller cell area. Consequently, when an image with large corneal endothelial cells is analysed by the current auto-analysis software, it detects the core of the cell as a cell wall, hence one cell would be recognised as two or more cells.
Recall Action	Recall for Product Correction
Recall Action Instructions	Device Technologies is providing a software upgrade to improve the detection of large size cells. End users are advised to evaluate the examination result of the Specular Microscope SP-1P not only with the resulting cell count, but also by reviewing the captured image while awaiting the software upgrade. This action has been closed-out on 19/02/2016.
Contact Information	1300 338 423 - Device Technologies