Reported May 29, 2019 · Terminated
AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291
Is this the product you have?
- AURIGA 30 BRAZIL ZERO COST SYSTEM UPNM0068S30BZ0
- Product UsageThe 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 includingUrology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery
- Lot codes and dates
- Serial Number
213029662130301621303021
- Serial Number
- Amount recalled
- 3 (OUS)
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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