| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01040-1 |
| Product Name/Description |
ATEC Canister (used with ATEC vacuum-assisted breast biopsy systems)
Lot Number: 20150013
ARTG Number: 215794 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Hologic have identified that the lid of the ATEC Canister may have cracks that are related to lost/no vacuum during an ATEC biopsy procedure.
This issue can be discovered during the inspection of the canister during setup or via a system vacuum error when testing the Eviva or ATEC biopsy needle. From customer complaints received to date there has not been any patient harm or other safety issue. However, the issue may prevent the system from enabling a procedure to continue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Hologic is advising users to inspect stocks and quarantine all affected units. Hologic will arrange for affected stock to be recovered and replacement stock, or a credit note, to be issued.
This action was closed out on the 24/09/2018. |
| Contact Information |
1800 264 073 – Hologic Australia |