Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0897-2018 — Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.

U.S. FDA — Device Enforcement · United States · 2017-09-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0897-2018
Date of alert
2017-09-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20413941
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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