Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/1/2008 Class:ll PRODUCT Radiation therapy system – PRIMEVIEW 3i System 2.1 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147675. Medical charged particle Radiation therapy system, part of the firm’s beam limiting device/accessory. The product provides data processing, and the SYNGO standard...Read More

Company: GE Healthcare Date of Enforcement Report 10/1/2008 Class:ll PRODUCT GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis, Recall # Z-1822-2008 REASON Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The...Read More

Company: GE Healthcare Date of Enforcement Report 10/1/2008 Class:ll PRODUCT GE Healthcare Definium 8000 Digital Radiographic System, Recall # Z-1882-2008 REASON Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety. Occasional...Read More

Company: Accuray, Inc Date of Enforcement Report 10/1/2008 Class:ll PRODUCT CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher, Recall # Z-2056-2008 REASON Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be...Read More

Company: Abbott Laboratories Date of Enforcement Report 10/1/2008 Class:ll PRODUCT ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, Part #7-201738-01; v2.20DB, Part #7-201738-02; v2.60, Part #7-203715-01; v3.10, Part #7-203715-02; 3.11, Part 7-203715-03; and 3.12. The Abbott ARCHITECT cSystem is designed to perform automated, random access, clinical chemistry...Read More