Z-0897-2018 Class II Terminated

Recalled by Boston Scientific Corporation — Marlborough, MA

Recall Details

Product Type
Devices
Report Date
March 14, 2018
Initiation Date
September 22, 2017
Termination Date
August 14, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.

Reason for Recall

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.

Distribution Pattern

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

Code Information

Serial Number: 20413941, 20143944