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U.S. Department of Health and Human Services

Class 2 Device Recall Auriga 30 Laser System

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 Class 2 Device Recall Auriga 30 Laser Systemsee related information
Date Initiated by FirmSeptember 22, 2017
Date PostedMarch 05, 2018
Recall Status1 Terminated 3 on August 14, 2018
Recall NumberZ-0897-2018
Recall Event ID 79096
510(K)NumberK111475 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductAuriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Code Information Serial Number: 20413941, 20143944
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactDonna M. Gardner
508-683-4398
Manufacturer 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.
FDA Determined
Cause 2		Process design
ActionUrgent 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**
Quantity in Commerce2
DistributionInternational Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEX
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