Medical Device Recall: 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 Stereotacti
Elekta Instrument AB · September 25, 2024
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
US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,
States Affected
AZ, CA, FL, GA, MO, NJ, NY, PA, TX, VA, WA
Quantity Affected
111 kits (666 needles)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0227-2025
Status: ongoing
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