August 21, 2008
Company: Varian Medical Systems Oncology Systems Date of Enforcement Report 8/20/2008 Class:ll PRODUCT Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or...
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Company: Sunquest Information Systems, Inc Date of Enforcement Report 8/20/2008 Class:ll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2 and v6.4.0 (Beta) Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta); Recall # B-1740-08 REASON Software, with a glitch or defect, was distributed RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson AZ,...
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Company: Roche Diagnostics Corp/Hitachi Ltd Date of Enforcement Report 8/20/2008 Class:ll PRODUCT a) Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry analyzer; Catalog number 04998618001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests; Z-0866-2008; b) Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyzer; Catalog...
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Company: Impac Medical Systems Inc. Date of Enforcement Report 8/20/2008 Class:ll PRODUCT SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO. Used to facilitate the delivery of defined radiotherapy treatment plans; Recall # Z-1515-2008 REASON Software issue may result in change to intended treatment field, Potentially resulting in mistreatment. RECALLING...
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Recipient: GE Healthcare Integrated IT Solutions Product: Centricity Imaging and other Picture Archiving and Communication System (PACS) products Date: 8/12/2008 1. Failure to establish and maintain adequate procedures for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential...
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Company: BD Biosciences Date of Enforcement Report 8/20/2008 Class:ll PRODUCT FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609 Flexible data acquisition and analysis package specifically designed for digital-based flow cytometers; Recall # Z-1525-2008 REASON When data file containing one or no fluoresence parameters is exported, the software will...
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