ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinica...
Reason: Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immatur...
Z-1500-2016April 27, 2016Tarrytown, NY
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Reason: Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cau...
Z-1521-2016April 27, 2016Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Reason: Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cau...
Z-1519-2016April 27, 2016Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Reason: Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly ca...
Z-1518-2016April 27, 2016Malvern, PA
Medtronic MiniMed Inc.
Class IITerminated
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
Reason: Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference...
Z-1501-2016April 27, 2016Northridge, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides softwa...
Reason: The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gam...
Z-1505-2016April 27, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance iCT SP 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: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Z-1353-2016April 20, 2016Cleveland, OH
Stryker Instruments Div. of Stryker Corporation
Class IITerminated
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in coun...
Reason: The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). ...
Z-1379-2016April 20, 2016Portage, MI
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core 128 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: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Z-1355-2016April 20, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core 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: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Z-1354-2016April 20, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity CT 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: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Z-1356-2016April 20, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance iCT 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: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Z-1352-2016April 20, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 64: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: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Z-1351-2016April 20, 2016Cleveland, OH
Neurotherm, Inc.
Class IITerminated
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Reason: NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in ...
Reason: Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when ...
Z-1269-2016April 6, 2016Brea, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
Cios Alpha, mobile X-ray system
Reason: Software issues on Cios Alpha mobile C-Arm system
Z-1278-2016April 6, 2016Malvern, PA
Viewray Incorporated
Class IITerminated
MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for ...
Reason: When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shif...
Z-1309-2016April 6, 2016Oakwood Village, OH
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Class IITerminated
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
Reason: Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" un...
Z-1244-2016March 30, 2016HIROSHIMA, N/A
CHG Hospital Beds Inc
Class IITerminated
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intende...
Reason: It was identified that in some situations the bed exit alarm may not function as intended. The software code for the bed exit system has the potential to auto-reset erroneously. ...
Z-1176-2016March 23, 2016London
Philips Respironics
Class IITerminated
Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the car...
Reason: Software Issue
Z-1065-2016March 16, 2016Monroeville, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and ...
Reason: Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabl...
Z-0862-2016March 2, 2016Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including q...
Reason: Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.
Z-0826-2016March 2, 2016Malvern, PA
Olympus Scientific Solutions Americas
Class IITerminated
Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
Reason: The Firm has discovered a Software bug.
Z-0803-2016March 2, 2016Waltham, MA
Toshiba American Medical Systems Inc
Class IITerminated
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Reason: When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the sof...
Z-0752-2016February 17, 2016Tustin, CA
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a...
Reason: Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Informati...