Elekta Instrument AB: Device Recall
Recall #Z-0227-2025 · 09/25/2024
Recall Details
- Recall Number
- Z-0227-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Elekta Instrument AB
- Status
- Ongoing
- Date Initiated
- 09/25/2024
- Location
- Stockholm, N/A, Sweden
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 111 kits (666 needles)
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.
Product Description
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 disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
Distribution Pattern
US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,