FDA recall Z-0898-2018

Product

Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. 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

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

Key facts

Status

Terminated

Initiation date

2017-09-22

Report date

2018-03-14

Termination date

2018-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0898-2018