—#172374

Product

AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 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 product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K111475
Affected lot / code info: Serial Number: 21302939, 21302937, 21302938

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 300 Boston Scientific Way, Marlborough, Massachusetts 01752-1291

Distribution

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

Timeline

Recall initiated: 2019-04-08
Posted by FDA: 2019-05-22
Terminated: 2023-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172374. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.