Z-0897-2018 Class II Terminated
FDA device recall Z-0897-2018 was initiated by Boston Scientific Corporation on September 22, 2017 and is designated Class II. 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 o… The recall status is terminated (terminated August 14, 2018). Affected quantity: 2.
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