OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the ...
Reason: Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
Reason: Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error.
Z-2542-2016August 24, 2016Tustin, CA
Ab Sciex
Class IITerminated
AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 3200MD series and 4500MD series are mass spectrometers intended to iden...
Reason: MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Z-2529-2016August 24, 2016Framingham, MA
Ab Sciex
Class IITerminated
AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5024500 3200MD series and 4500MD series are mass spectrometers intended to iden...
Reason: MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Z-2527-2016August 24, 2016Framingham, MA
Merge Healthcare, Inc.
Class IITerminated
iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet...
Reason: Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Stu...
Z-2531-2016August 24, 2016Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, ...
Reason: The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
Z-2551-2016August 24, 2016Hartland, WI
Ab Sciex
Class IITerminated
AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 3200MD series and 4500MD series are mass spectrometers intended to...
Reason: MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Z-2528-2016August 24, 2016Framingham, MA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Reason: Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.
Z-2382-2016August 17, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.
Reason: Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
Z-2384-2016August 17, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
Reason: Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment.
Z-2380-2016August 17, 2016Cleveland, OH
Merge Healthcare, Inc.
Class IITerminated
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of dig...
Reason: When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are...
Z-2363-2016August 17, 2016Hartland, WI
Siemens Healthcare Diagnostics Inc
Class IITerminated
Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, ...
Reason: Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibrati...
Z-2525-2016August 17, 2016Norwood, MA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles an...
Reason: Software defect causing intermittently slow response of Host.
Z-2367-2016August 17, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason: Software defect causing intermittently slow response of Host.
Reason: The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used...
Z-2346-2016August 17, 2016Cleveland, OH
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee ...
Reason: Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup.
Z-2344-2016August 17, 2016Malvern, PA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and p...
Reason: Software defect causing intermittently slow response of Host.
Reason: The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used...
Z-2347-2016August 17, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
Reason: Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
Z-2385-2016August 17, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Reason: Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment.
Z-2383-2016August 17, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles a...
Reason: Software defect causing intermittently slow response of Host.
Z-2368-2016August 17, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
Reason: Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment.
Z-2381-2016August 17, 2016Cleveland, OH
Merge Healthcare, Inc.
Class IITerminated
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Reason: The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
Z-2379-2016August 17, 2016Hartland, WI
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason: Software defect causing intermittently slow response of Host.
Z-2366-2016August 17, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason: Software defect causing intermittently slow response of Host.