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Recall Observatory FDA recall evidence

Device product

Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

Z-2442-2020

June 10, 2020

Class II

Product summary

Firm
Elekta Instrument AB
Event
Event 85836
Status
Terminated
Classification
Class II
Quantity
51 devices
Official record key
device-enforcement:Z-2442-2020

Official wording

Reason: The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.

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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.