Company: Beckman Coulter Inc.Date of Enforcement Report: 6/5/2013 Class ll: PRODUCT Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration...Read More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 6/5/2013 Class ll: PRODUCT RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number Z-1419-2013 REASON Under some circumstances, imported CT, MR and...Read More

Company: Intel-GE Care Innovations LLC .Date of Enforcement Report: 5/29/2013 Class ll: PRODUCT QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. Recall Number Z-1374-2013 and Z-1375-2013 REASON ers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. RECALLING FIRM/MANUFACTURER Intel-GE...Read More

Company: Alpine Biomed Aps.Date of Enforcement Report: 6/5/2013 Class ll: PRODUCT Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV, 9033A0044, 9033A0073AA, 9031A0063, 9033A0523, 9033A071143, 9033A072143, 9031A006406, 9031A006506, 9031A070106, 9033A004606 9033A004706, 9033A007406, 9033A0537, 9033A0544, 9033A071106, 9033A072106, 9033A0524,...Read More

Company: Canon Inc.Date of Enforcement Report: 6/5/2013 Class ll: PRODUCT Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. Recall Number Z-1404-2013 REASON Canon Inc. had received 17 claims from our foreign...Read More