Brainlab AG recalls BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 0405648

Recalled August 19, 2020 · FDA recall Z-2792-2020 · Brainlab AG

Hazard

Incorrect manufacturer calibration · FDA Class II

Units

18 units

Sold at

USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain

Description

Incorrect manufacturer calibration

Product

BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011

Manufacturer(s)

Brainlab AG

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →