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Recall Observatory FDA recall evidence

Device product

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

Z-0898-2018

September 22, 2017

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 79096
Status
Terminated
Classification
Class II
Quantity
9
Official record key
device-enforcement:Z-0898-2018

Official wording

Reason: 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.

Code information: Serial Number: 20509715, 20465096, 20503137, 20520960, 20541967, 20546219, 20546440, 20575512, and 20575518.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.