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Terminated

AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.

FDA Recall Z-1395-2019 · Posted 2019-05-22

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeGEX
Date Initiated2019-04-08
Date Terminated2023-05-10
Product Quantity8 (OUS)

Reason for Recall

Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.

Firm Action

Boston Scientific issued to the user level the correction/removal via a customer notification letter via FedEx or hand delivery by a Boston Scientific agent on 4/9/19. Letter provides recommendations to the user until a field repair can be completed or a replacement console can be provided. A Boston Scientific representative will be in contact with you directly to schedule a field repair or replacement at your facility. The console can continue to be used during this time following the recommendations within the letter.

Root Cause

Component design/selection

Distribution Pattern

Worldwide distribution to Australia, Belgium, Brazil, Chile, Colombia, Egypt, France, Germany, Great Britain, India, Indonesia, Iran, Italy, Lebanon, Malaysia, Mexico, Romania, Russia Fed., South Africa, South Korea, Spain, Taiwan, United Arab Emirates and Vietnam

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111475AURIGA XLStarmedtec GmbH · 2011-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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