AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 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.
This recall has been terminated (originally issued May 22, 2019).
- Company
- Boston Scientific Corporation
- Recall Initiated
- April 8, 2019
- Posted
- May 22, 2019
- Terminated
- May 10, 2023
- Recall Number
- Z-1392-2019
- Quantity
- 27 (OUS)
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
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.
Distribution
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
Lot / Code Info
Serial Number: 21302771, 21302815, 21302786, 21302800, 21302843, 21302928, 21302842, 21302915, 21302900, 21302933, 21302783, 21302922, 21302934, 21302935, 21302942, 21302956, 21302957, 21302989, 21303002, 21303000, 21303001, 21303067, 21303004, 21303044, 21303042, 21302899, 21303091
Root Cause
Component design/selection
Action Taken
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.