Company: Varian Medical Systems, Inc. Date of Enforcement Report:1/1/2014 Class lI: PRODUCT Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation. Recall Number Z-0552-2014 REASON An anomaly...Read More

Company: EOS Imaging Date of Enforcement Report:1/1/2014 Class lI: PRODUCT steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images. Recall Number Z-0580-2014 REASON Error copying information to...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report:1/1/2014 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in...Read More

Company: Mckesson Information Solutions LLC Date of Enforcement Report:1/1/2014 Class lI: PRODUCT McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). Recall Number Z-0556-2014 REASON When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy information for the second patient record. RECALLING FIRM/MANUFACTURER Mckesson...Read More

Company: Data Innovations, Inc. Date of Enforcement Report:1/1/2014 Class lI: PRODUCT Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004 Recall Number Z-0571-2014 REASON When connected to the Sysmex UF-100, the...Read More

Company:CareFusion 303, Inc.. Date of Enforcement Report:1/1/2014 Class l: PRODUCT Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia)...Read More