Elekta Instrument AB recalls Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
- Recall date
- June 10, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2442-2020
- FDA classification
- Class II
- Brand / firm
- Elekta Instrument AB
- Sold / distributed
- 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
Why it was recalled
The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
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