Abbott Vascular - Absorb Bioresorbable Vascular Scaffold (BVS) System - Class 1 Recall
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with reference vessel diameters e 2.0 mm and d 3.8 mm. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Abbott Vascular - Absorb Bioresorbable Vascular Scaffold (BVS) System, Absorb GT1 Bioresorbable Vascular Scaffold BVS - Class 1 Recall
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia and European Union). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with reference vessel diameters e 2.0 mm and d 3.8 mm. The Absorb GT1 Bioresorbable Vascular Scaffold (BVS) is a temporary scaffold that will fully resorb over time and i...
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Roche Diagnostics Operations, Inc. - TinaQuant (Latex) HS Test System (CReactive Protein (Latex) High Sensitive) - Class 2 Recall
Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Highly sensitive measurement of CRP is of use for the detection and evaluation of inflammatory disorders, and associated diseases, infection and tissue injury. Measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods o...
Source: Medical Device Recalls - January 25, 2017 Category: Medical Equipment Source Type: alerts
AGFA Corp. - IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognitio - Class 2 Recall
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. The IMPAX CV Reporting component facilitates the quick effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 28, 2014 Category: Medical Equipment Source Type: alerts
AGFA Corp. - IMPAX CV 7.8 SU3 OCR Service - Class 2 Recall
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2013 Category: Medical Equipment Source Type: alerts
AGFA Corp. - IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting - Class 2 Recall
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2013 Category: Medical Equipment Source Type: alerts
