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U.S. Department of Health and Human Services

Class 1 Device Recall Elekta Leksell Stereotactic System

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 Class 1 Device Recall Elekta Leksell Stereotactic Systemsee related information
Date Initiated by FirmSeptember 25, 2024
Date PostedNovember 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0227-2025
Recall Event ID 95484
510(K)NumberK152558 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductElekta 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.
Code Information Batch Number 873874875R Package including 6 needles: UDI: (01)0 7340048 30034 6 (17) 260301 (10) 873874875R (240) 911933 Package including 1 needle: UDI: (01)0 7340048 30800 7 (17) 260301 (10) 873874875R (240) 911761 Inner sterile bag including 1 needle: UDI: (01)0 7340048 30801 4 (17) 260301 (10) 873874875R (240) 912465
FEI Number 3002806883
Recalling Firm/
Manufacturer		 Elekta Instrument AB
Kungstensgatan 18
Stockholm Sweden
For Additional Information Contact
46 8 425400
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionElekta 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 in Commerce111 kits (666 needles)
DistributionUS: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HAW
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