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U.S. Department of Health and Human Services

Class 2 Device Recall Leksell Vantage Stereotactic System

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  Class 2 Device Recall Leksell Vantage Stereotactic System see related information
Date Initiated by Firm June 10, 2020
Create Date July 10, 2020
Recall Status1 Completed
Recall Number Z-2442-2020
Recall Event ID 85836
510(K)Number K171123  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Code Information Serial numbers: SH00026, SH00049, SH00061, SH00082, SH00092, SH00111, SH00028, SH00050, SH00072, SH00084, SH00094, SH00118, SH00029, SH00052, SH00073, SH00085, SH00095, SH00121, SH00030, SH00054, SH00074, SH00086, SH00097, SH00123, SH00032, SH00055, SH00077, SH00087, SH00099, SH00127, SH00033, SH00057, SH00078, SH00088, SH00100, SH00162, SH00041, SH00058, SH00079, SH00089, SH00102, SH00044, SH00059, SH00080, SH00090, SH00105, SH00045, SH00060, SH00081, SH00091, SH00108
Recalling Firm/
Manufacturer		 Elekta Instrument AB
Kungstensgatan 18
Stockholm Sweden
Manufacturer Reason
for Recall		 The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
FDA Determined
Cause 2		 Device Design
Action The firm notified their consignees on 06/10/2020 by email. The notice explained the problem and provided directions on the removal of the spring. The firm offered assistance with the removal and provided the following contact: Neurosupport@elekta.com.
Quantity in Commerce 51 devices
Distribution MA, IL, NH, NC, UT, OH, FL, MN, TX, NY, LA, AZ, MT, WV, Austria, Croatia, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lithuania, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom
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.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = Elekta Instrument AB
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