| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01358-1 |
| Product Name/Description |
TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk)
ARTG Number: 227987 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/10/2016 |
| Responsible Entity |
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| Reason/Issue |
It has been identified that the FRAX adjusted for TBS values are not correct when the FRAX feature is activated in TBS iNsight and TBS has been computed from a spine scan where some vertebrae were excluded. This does not affect the Trabecular Bone Scores. Patient fracture risk evaluations could be altered based on this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Inovanz has advised users of a new software version, v.3.0.2, that is available and incorporates a permanent fix for this issue. In the interim, Inovanz has advised users to immediately deactivate the FRAX adjusted for TBS feature. In addition, a tool is being provided that will automatically analyse and provide a detailed report for all erroneous fracture risk evaluations with v.3.0.1. This action has been closed-out on 24/05/2017. |
| Contact Information |
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