| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00843-1 |
| Product Name/Description |
Disposable Biopsy Needles (911933)
Batch number: 873874875R
ARTG 312134
(Elekta Pty Ltd - Leksell Stereotactic System - Stereotactic surgery system, neurological) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (873874875R) can contain some microscopic debris on the inside of the biopsy needle.
The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.
The sterility of the biopsy needles has not been affected. |
| Recall Action |
Recall |
| Recall Action Instructions |
All Disposable Biopsy Needles (911933) from batch 873874875R should be removed from clinical use and disposed of as per standard protocols.
Please contact your local Elekta representative for ordering replacement needle kits. |
| Contact Information |
mike.bufton@elekta.com - Mike Bufton |