Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner
FDA device recall Z-0227-2025 · posted 2024-11-06 · Open, Classified
Recall details
- Recalling firm
- Elekta Instrument AB
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- HAW
- Quantity affected
- 111 kits (666 needles)
- Distribution
- US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,
- Date initiated
- 2024-09-25
- Date posted
- 2024-11-06
- Location
- Stockholm, Sweden
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Leksell Stereotactic System, Injection/ Aspiration Needle Kit (K152558) | Elekta Instrument AB | 2016-03-02 |