Recall Z-0227-2025 ยท HAW Neurological Stereotaxic Instrument
Elekta Instrument AB
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial diso
| Date | Nov 6, 2024 (initiated Sep 25, 2024) |
| Status | Open, Classified |
| Reason | Elekta has become aware that Disposable Biopsy Needles 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. |
| Root cause | Under Investigation by firm |
| Action | Elekta issued an URGENT IMPORTANT FIELD SAFETY NOTIFICATION to its consignees on 069/23/2023 via email. Then notice explained the problem, clinical impact, and requested the destruction of the affected product. Contact the local Elekta representative for alternative solutions. They also requested that the notice be posted in a place accessible to all users until this action is closed and to notify all appropriate personnel working with this product of the content of the notice. |
| Quantity | 111 kits (666 needles) |
| Distribution | US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle Kit Elekta Instrument AB, Mar 2, 2016 |