RecallRadar

FDA Device recall Z-0897-2018

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

On 2018-03-14 the FDA classified a Class II recall of Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures by Boston Scientific, citing 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 re….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0897-2018
ClassificationClass II
Statusterminated
Initiated2017-09-22
Published2018-03-14
Last updated2026-09-13 11:54 UTC
CompanyBoston Scientific
Distributionn/a

Product

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

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.

Identifiers

code_infoSerial Number: 20413941, 20143944

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0897-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.