Device Recall Visualase Cooled Laser Applicator System (VCLAS)
모델명 / 제조번호(시리얼번호)
All lot numbers manufactured by BioTex are affected for Model Numbers: T03: 001-4003 - VCLAS 001-4003 .4mm CORE FIBER 3mm TIP T10: 001-4000 - VCLAS 001-4000 .4mm CORE FIBER 10mm TIP T15: 001-6000 - VCLAS 001-6000 .6mm CORE FIBER 15mm TIP
Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.
제품 설명
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). || The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.