Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treati...
Reason: Cross profile for Varian 60 degree wedge shows "horns."
Z-0987-2017January 18, 2017Atlanta, GA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional p...
Reason: Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G ...
Z-0971-2017January 18, 2017Malvern, PA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruc...
Reason: Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.
Z-1006-2017January 18, 2017Cleveland, OH
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional pr...
Reason: Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G ...
Z-0972-2017January 18, 2017Malvern, PA
Merge Healthcare, Inc.
Class IITerminated
DR Systems Unity PACS software, now known as Merge Unity PACS software.
Reason: The software fails to associate to the correct MG image if there are two images for the same view.
Z-0939-2017January 11, 2017Hartland, WI
PerkinElmer Health Sciences, Inc.
Class IITerminated
Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, ...
Reason: Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.
Z-0902-2017January 4, 2017Waltham, MA
Neusoft Medical Systems Co., Ltd.
Class IITerminated
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
Reason: The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be pow...
Z-0876-2017January 4, 2017Shenyang, N/A
Radiometer America Inc
Class IITerminated
AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results...
Reason: Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Z-0899-2017December 28, 2016Brea, CA
Merge Healthcare, Inc.
Class IITerminated
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason: Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.
Z-0878-2017December 28, 2016Hartland, WI
Accuray Incorporated
Class IITerminated
CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment p...
Reason: Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife¿ Systems w...
Z-0734-2017December 21, 2016Sunnyvale, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane...
Reason: Software update that provides software and firmware bug-fixes to improve system performance
Z-0742-2017December 21, 2016Malvern, PA
Merge Healthcare, Inc.
Class IITerminated
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurem...
Reason: If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the ...
Z-0729-2017December 21, 2016Hartland, WI
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial pl...
Reason: Software update that provides software and firmware bug-fixes to improve system performance
Z-0743-2017December 21, 2016Malvern, PA
Olympus Corporation of the Americas
Class IITerminated
HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
Reason: Software malfunction that results in incorrect generation or display of error codes.
Z-0754-2017December 21, 2016Center Valley, PA
Merge Healthcare, Inc.
Class IITerminated
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images,...
Reason: Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
Z-0730-2017December 21, 2016Hartland, WI
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial pla...
Reason: Software update that provides software and firmware bug-fixes to improve system performance
Z-0744-2017December 21, 2016Malvern, PA
RAYSEARCH LABORATORIES AB
Class IITerminated
Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment...
Reason: An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with t...
Z-0720-2017December 14, 2016Stockholm, N/A
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity CT 728326 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 and planes...
Reason: Software error due to the filament on timer
Z-0697-2017December 14, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core 728321 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 and plan...
Reason: Software error due to the filament on timer
Z-0695-2017December 14, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 64 728231 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 and plane...
Reason: Software error due to the filament on timer
Z-0693-2017December 14, 2016Cleveland, OH
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The ...
Reason: Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. For treatment plans with a combination of ran...
Z-0721-2017December 14, 2016Stockholm, N/A
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 64 728232 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 and plane...
Reason: Software error due to the filament on timer
Z-0694-2017December 14, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core 128 728323
Reason: Software error due to the filament on timer
Z-0696-2017December 14, 2016Cleveland, OH
Merge Healthcare, Inc.
Class IITerminated
Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and d...
Reason: A product issues happens for RF projection images. If user measures on RF image, .cal (Calibration) is not displayed and measurement is not correct. The .cal label is not displayed...
Z-0707-2017December 14, 2016Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, includ...
Reason: Cut lines on the image may present horizontally rather than vertically.