Company: Misys Healthcare Systems, Date of Enforcement Report:5/17/2006 Class:lI PRODUCT Misys Laboratory Blood Bank Module, Version 6.1, Recall # B-1065-6 REASON Defects in the design of software could result in data being out of sync with the accession number, patient and/or units displayed on the screen. CODE Version 6.1 RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson,...Read More

Company: General Electric Medical Systems LLC,, Date of Enforcement Report:5/17/2006 Class:lI PRODUCT Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software (Version 4.0, 4.1, or 4.2), Recall # Z-0854-06 REASON Display in fused mode- viewer allows 2 studies ( PET/CT) registered in the same spatial domain to be viewed simultaneously....Read More

Company: AGFA Corporation., Date of Enforcement Report:5/17/2006 Class:lI PRODUCT CR DX-S, DX-S, Computed radiography system (Digitizer), Software versions: STR1102B and below, Recall # Z-0855-06 REASON Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop CODE Serial numbers: SN10001-SN1079 RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corporation, Greenville,...Read More

Company:Affymetrix, Inc., Date of Enforcement Report:5/17/2006 Class:lIl PRODUCT Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software, Recall # Z-0853-06 REASON Incorrect software version of instrument controller is not compatible with new configuration. This incorrect configuration may cause the instrument system to fail at start-up or...Read More