FDA-Device2020-08-19Class II
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Brainlab AG
Hazard
Incorrect manufacturer calibration
Sold states
USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain
Affected count
18 units
Manufactured in
Olof-palme-str. 9, N/A, Munich, N/A, Germany
Products
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2792-2020Don't want to check this manually?
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