Z-1396-2019 Class II Terminated
FDA device recall Z-1396-2019 was initiated by Boston Scientific Corporation on April 8, 2019 and is designated Class II. 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 sc… The recall status is terminated (terminated May 10, 2023). Affected quantity: 3 (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- April 8, 2019
- Termination Date
- May 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 (OUS)
Product Description
AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 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.
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 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
Code Information
Serial Number: 21302966, 21303016, 21303021