Company: Siemens Medical SolutionsUSADate of Enforcement Report 4/20/2011 Class ll: PRODUCT Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461; The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional,...Read More

Company: Quest Medical Inc. Date of Enforcement Report 4/20/2011 Class lll: PRODUCT Quest MPS and MPS 2 Consoles. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a...Read More

Company: Gambro Renal Products, IncDate of Enforcement Report 4/20/2011 Class ll: PRODUCT Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Recall # Z-1901-2011 REASON Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure. RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro Renal...Read More

Company: Hamilton Medical Inc Date of Enforcement Report 4/20/2011 Class ll: PRODUCT Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; Neonatal Software catalog number: 159700; Neonatal Option catalog number: 159187. Hamilton Medical Intended for use in the hospital and institutional environment where healthcare professionals provide...Read More

Company: GE Healthcare LLCDate of Enforcement Report 4/20/2011 Class ll: PRODUCT GE the CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE Monitor B850 host processing unit running the CARESCAPE Monitoring platform software, a display with integrated keyboard...Read More

Company: GE Healthcare LLC Date of Enforcement Report 4/20/2011 Class ll: PRODUCT 1) GE Healthcare, CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients...Read More