| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00866-1 |
| Product Name/Description |
Merge CADstream, All versions (used for breast cancer or general MRI studies)
All versions are affected
ARTG Number: 165390 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Within the SureLoc application, under SureLoc Preferences, there are two grid options: a generic grid or the GE 8-Channel Curved Grid. A generic grid is a flat grid of 2 centimeter holes. There is no limitation on the number of blocks. Selecting the incorrect grid or using an unsupported grid could result in an incorrect biopsy or missed target. There is a chance that a repeat biopsy may be required. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Emergo is advising users to ensure a verification scan is completed as per the User Guide to confirm correct placement prior to undertaking a biopsy. Users are also advised that if they are using a grid outside the two defined options, please contact Merge support. This action has been closed-out on 27/02/2017. |
| Contact Information |
02 9006 1662 - Emergo Australia |