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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 System see related information
Date Initiated by Firm March 15, 2024
Date Posted April 16, 2024
Recall Status1 Open3, Classified
Recall Number Z-1397-2024
Recall Event ID 94197
510(K)Number K152558  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm 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.
Code Information Lot number 837838839 appears on the labels for REF 911933, REF 911761, and REF 912465. UDI numbers: REF 911933 - (01)0 7340048 30034 6, (17)250401 (10) 837838839 (240) 911933; REF 911761 - (01)0 7340048 30800 7, (17)250401 (10) 837838839 (240) 911761; REF 912465 - (01)0 7340048 30801 4, (17)250401 (10) 837838839 (240) 912465.
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 (911933) from one batch (837838839) 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. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.
FDA Determined
Cause 2		 Under Investigation by firm
Action Elekta issued an URGENT RECALL NOTIFICATION to its consignees on 03/05/2024 via email. The notice explained the problem, potential risk, and requested that the consignee advise appropriate personnel and destroy the affected product.
Quantity in Commerce 601 needles
Distribution US and Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HAW and Original Applicant = ELEKTA INSTRUMENT AB
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