Reason: Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
Z-0497-2019December 26, 2018Mansfield, MA
GE Healthcare, LLC
Class IITerminated
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientat...
Reason: Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and vertically, the orientation mar...
Z-0641-2019December 26, 2018Waukesha, WI
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the an...
Reason: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Z-0651-2019December 26, 2018Rochester, NY
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to dete...
Reason: Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the...
Z-0617-2019December 26, 2018Newark, DE
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITRO...
Reason: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Z-0650-2019December 26, 2018Rochester, NY
bioMerieux, Inc.
Class IITerminated
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Reason: The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) ...
Z-0639-2019December 26, 2018Durham, NC
PerkinElmer Health Sciences Canada, Inc.
Class IITerminated
PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Pa...
Reason: Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3Q MD and Hotfix 2 software, it is possible for the original data from the last acqu...
Z-0513-2019December 5, 2018Bolton, N/A
Synaptive Medical Inc
Class ITerminated
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s cus...
Reason: This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is s...
Z-0470-2019December 5, 2018Toronto, N/A
Beckman Coulter Inc.
Class ITerminated
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
Reason: A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plot...
Z-0471-2019November 28, 2018Brea, CA
Tosoh Bioscience Inc
Class IITerminated
Tosoh AIA-900 immunoassay Analyzer
Reason: A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released softw...
Z-0485-2019November 28, 2018Grove City, OH
Beckman Coulter Inc.
Class ITerminated
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
Reason: A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plot...
Z-0472-2019November 28, 2018Brea, CA
Invivo Corporation
Class IICompleted
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Reason: The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or...
Z-0462-2019November 21, 2018Orlando, FL
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IIOngoing
Medtronic CareLink Encore 29901 Programmer
Reason: Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an ...
Reason: O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new...
Z-0404-2019November 14, 2018Littleton, MA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IIOngoing
Medtronic CareLink 2090 Programmer
Reason: Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an ...
Z-0406-2019November 14, 2018Mounds View, MN
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recon...
Reason: It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provid...
Z-0307-2019November 7, 2018Cleveland, OH
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Reason: Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
Z-0294-2019November 7, 2018Stockholm, N/A
Beckman Coulter Inc.
Class IIITerminated
Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit whic...
Reason: Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. Sorting Dr...
Z-0358-2019November 7, 2018Brea, CA
Fresenius Vial Sa
Class IITerminated
Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthca...
Reason: Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience while preventing comm...
Z-0362-2019November 7, 2018Brezins, N/A
Beckman Coulter Inc.
Class IIITerminated
Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 F...
Reason: Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing of barcodes. When ...
Z-0354-2019November 7, 2018Brea, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ra...
Reason: It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provid...
Z-0309-2019November 7, 2018Cleveland, OH
Beckman Coulter Inc.
Class IIITerminated
Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes t...
Reason: Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes.Sorting Dri...
Z-0359-2019November 7, 2018Brea, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstructio...
Reason: It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provid...
Z-0311-2019November 7, 2018Cleveland, OH
Beckman Coulter Inc.
Class IIITerminated
Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client f...
Reason: Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. Sorting Dr...
Z-0353-2019November 7, 2018Brea, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X...
Reason: Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Softwar...