| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00177-1 |
| Product Name/Description |
Disposable Biopsy Needle Kit
Product Description: 911933
Batch Number: 837838839
Expiry Date: 01/04/2025
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 |
5/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) 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.
There is a risk that debris can come loose and appear in the biopsy sample.
Debris in the biopsy sample may interfere with the slicing of the biopsy sample and delay or make examination difficult.
There is also a very low risk that debris is deposited in the brain. |
| Recall Action |
Recall |
| Recall Action Instructions |
Due to the clinical impact of this issue, all Disposable Biopsy Needles (911933) from batch 837838839 must be removed from clinical use and disposed.
Customers should contact their local Elekta representative for ordering replacement needle kits.
Elekta is investigating necessary actions to prevent the recurrence of this issue. |
| Contact Information |
mike.bufton@elekta.com - Mike Bufton |