FDA-Device2020-07-08Class II
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Elekta Instrument AB
Hazard
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
Sold states
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
Affected count
51 devices
Manufactured in
Kungstensgatan 18, N/A, Stockholm, N/A, Sweden
Products
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2442-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief