Boston Scientific Corporation recalls Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.

Recall date

September 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0898-2018

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.