Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
FDA Recall Z-0897-2018 · Posted 2018-03-05
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeGEX
Date Initiated2017-09-22
Date Terminated2018-08-14
Product Quantity2
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.
Firm Action
Urgent Medical Device Field Correction letters, dated September 2017, were sent to distributors and medical facilities with instructions for acknowledging the notice and making corrections. The letter identified the affected device and the reason for the correction. Customers were to check their inventory, segregate, and cease distribution for the affected devices. Customers were to complete and return the acknowledgment form.
**NO PRODUCT IS BEING RECALLED AND YOU ARE NOT REQUIRED TO RETURN PRODUCT TO BOSTON SCIENTIFIC**
Root Cause
Process design
Distribution Pattern
International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.