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Boston Scientific Corporation recalls Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Recalled March 14, 2018 · FDA recall Z-0897-2018 · Boston Scientific
Hazard
Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console. · FDA Class II
Units
2
Sold at
International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
Description
Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
Product
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →