FDA-Device2018-03-14Class II
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Boston Scientific Corporation
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.
Sold states
International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
Affected count
2
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0897-2018Don't want to check this manually?
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