Company: GE Healthcare It Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Siemens CentraLink” Data Management System V14.0.4, V14.0.5 or V14.0.8_x000D_ _x000D_ The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected...Read More

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems._x000D_ _x000D_ Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. Recall Number Z-0800-2014 REASON An overflow flag //// is displayed in the result column for a test when the...Read More

Company: Carestream Health, Inc. Date of Enforcement Report:2/5/2014 Class lI: PRODUCT KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608. Made in U.S.A. Recall Number Z-0844-2014 REASON Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to...Read More

Company: Integra LifeSciences Corp.. Date of Enforcement Report:2/5/2014 Class lI: PRODUCT ntegra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA_x000D_ _x000D_ The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or...Read More

Company: GE Healthcare LLC Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. _x000D_ _x000D_ Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-0840-2014 REASON There is an issue with the...Read More

Company: GE Healthcare It Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout...Read More

Company: GE Healthcare It Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Centricity PACS System versions 3.X and higher and 4.X and higher_x000D_ Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It...Read More

Company: DeRoyal Industries Inc Date of Enforcement Report:2/5/2014 Class lI: PRODUCT 1. Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China._x000D_ _x000D_ Physical Therapy. Recall Number Z-0834-2014 2. DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx...Read More