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Elekta Instrument AB recalls Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Recalled July 8, 2020 · FDA recall Z-2442-2020 · Elekta Instrument AB
Hazard
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly. · FDA Class II
Units
51 devices
Sold at
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
Description
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
Product
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Manufacturer(s)
Elekta Instrument AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →