IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes...
Reason: A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
Z-0705-2017December 14, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body mat...
Reason: A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
Z-0706-2017December 14, 2016Cleveland, OH
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Force, System x-ray, tomography, computed
Reason: Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global Complaint Handling Proces...
Z-0692-2017December 14, 2016Malvern, PA
Merge Healthcare, Inc.
Class IITerminated
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
Reason: Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be ...
Z-0664-2017December 7, 2016Hartland, WI
Roche Diagnostics Operations, Inc.
Class IITerminated
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended ...
Reason: Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue ...
Z-0673-2017December 7, 2016Indianapolis, IN
Merge Healthcare, Inc.
Class IITerminated
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of...
Reason: The application may crash during the cath lab procedure.
Z-0665-2017December 7, 2016Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface an...
Reason: It was reported by a customer that RadSuite images are not appearing as readable images. This product malfunction has the potential to result in delay in care and a possible r...
Z-0614-2017November 30, 2016Hartland, WI
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstru...
Reason: Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition F...
Z-0607-2017November 23, 2016Malvern, PA
Merge Healthcare, Inc.
Class IITerminated
Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital m...
Reason: The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.
Z-0599-2017November 23, 2016Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
Merge LIS software.
Reason: There is a potential for duplicate container numbers to be created for patients.
Z-0399-2017November 23, 2016Hartland, WI
Roche Diabetes Care, Inc.
Class IITerminated
Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
Reason: Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software cont...
Z-0586-2017November 23, 2016Indianapolis, IN
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruct...
Reason: Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition F...
Z-0606-2017November 23, 2016Malvern, PA
Merge Healthcare, Inc.
Class IITerminated
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason: Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
Z-0611-2017November 23, 2016Hartland, WI
Mevion Medical Systems, Inc.
Class IITerminated
MEVION S250 Product Usage: Proton Radiation Therapy System
Reason: Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases ...
Z-0411-2017November 23, 2016Littleton, MA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstr...
Reason: Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition F...
Z-0608-2017November 23, 2016Malvern, PA
Roche Diagnostics Operations, Inc.
Class IITerminated
Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performin...
Reason: cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A softwar...
Z-0387-2017November 16, 2016Indianapolis, IN
Medimaps Group
Class IITerminated
TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.
Reason: The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded.
Z-0369-2017November 16, 2016Plan-les-Ouates
Ortho-Clinical Diagnostics
Class IITerminated
enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Mod...
Reason: Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for m...
Z-0300-2017November 2, 2016Rochester, NY
Roche Diagnostics Operations, Inc.
Class IITerminated
RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled s...
Reason: Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has ...
Z-0104-2017November 2, 2016Indianapolis, IN
Intuitive Surgical, Inc.
Class IITerminated
da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Mo...
Reason: Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certa...
Z-0315-2017November 2, 2016Sunnyvale, CA
Roche Diagnostics Operations, Inc.
Class IITerminated
cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for ...
Reason: Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has b...
Z-0106-2017November 2, 2016Indianapolis, IN
Merge Healthcare, Inc.
Class IITerminated
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason: The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. ...
Z-0137-2017October 26, 2016Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream ...
Reason: Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.
Z-0118-2017October 26, 2016Hartland, WI
Fujifilm Medical Systems U.S.A., Inc.
Class IITerminated
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of ima...
Reason: Image data for a patients image may not be correct
Z-0073-2017October 19, 2016Stamford, CT
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of ra...
Reason: RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The correction concerns two issues f...