DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Reason: In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calcula...
Z-0745-2016February 10, 2016Andover, MA
Mindray DS USA, Inc. dba Mindray North America
Class IITerminated
Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The ...
Reason: An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will b...
Z-0701-2016February 10, 2016Mahwah, NJ
Bio-Rad Laboratories, Inc.
Class IITerminated
D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagen...
Reason: On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.
Z-0695-2016February 3, 2016Hercules, CA
Brainlab AG
Class ITerminated
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localizat...
Reason: Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure th...
Z-0598-2016January 27, 2016Munich, N/A
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in...
Reason: Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. W...
Z-0641-2016January 20, 2016Rochester, NY
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier...
Reason: Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. W...
Z-0643-2016January 20, 2016Rochester, NY
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in...
Reason: Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. W...
Z-0640-2016January 20, 2016Rochester, NY
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is inten...
Reason: Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. W...
Z-0642-2016January 20, 2016Rochester, NY
Philips Ultrasound, Inc.
Class IITerminated
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
Reason: Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or Velocity Markers. (e....
Z-0596-2016January 13, 2016Bothell, WA
Siemens Medical Solutions USA, Inc
Class IITerminated
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Reason: Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquire...
Z-0597-2016January 13, 2016Malvern, PA
KCI USA, INC.
Class IITerminated
ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies nega...
Reason: There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.
Z-0600-2016January 13, 2016San Antonio, TX
Elekta, Inc.
Class IITerminated
Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in...
Reason: When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could resul...
Z-0604-2016January 13, 2016Atlanta, GA
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Class IITerminated
Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive ...
Reason: During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity.
Z-0581-2016January 13, 2016Oakville, N/A
Merge Healthcare, Inc.
Class IITerminated
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheteriza...
Reason: The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
Z-0554-2016January 6, 2016Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
Merge Cardio with software version 10.1 LA.
Reason: The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
Z-0555-2016January 6, 2016Hartland, WI
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core 128 Computed Tomography X-ray system
Reason: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions p...
Z-0548-2016December 30, 2015Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 64 Computed Tomography X-ray system
Reason: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions p...
Z-0544-2016December 30, 2015Cleveland, OH
Shimadzu Medical Systems
Class IITerminated
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical fac...
Reason: The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
Z-0451-2016December 30, 2015Torrance, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity CT Computed Tomography X-ray system
Reason: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions p...
Z-0549-2016December 30, 2015Cleveland, OH
Draeger Medical, Inc.
Class ITerminated
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
Reason: The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexp...
Z-0436-2016December 30, 2015Telford, PA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core Computed Tomography X-ray system
Reason: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions p...
Z-0547-2016December 30, 2015Cleveland, OH
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
Reason: For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in ...
Z-0550-2016December 30, 2015Malvern, PA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance iCT SP Computed Tomography X-ray system
Reason: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions p...
Z-0546-2016December 30, 2015Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance iCT Computed Tomography X-ray system
Reason: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions p...
Z-0545-2016December 30, 2015Cleveland, OH
bioMerieux, Inc.
Class IITerminated
MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and th...
Reason: MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same speci...