Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 3/18/2015 Class lI: PRODUCT VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with VITROS Analyzer Systems. Recall Number Z-1263-2015 REASON...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 3/18/2015 Class lI: PRODUCT SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Product Usage: The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at...Read More

Company: Villa Radiology Systems LLC. Date of Enforcement Report 3/18/2015 Class lI: PRODUCT Juno DFR x-ray system Recall Number Z-1079-2015 REASON It has been discovered that the system – does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality RECALLING FIRM/MANUFACTURER Villa Radiology Systems LLC,...Read More