Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
Reason: Potential data loss occurs as a result of product archiving not working properly.
Z-2159-2016July 20, 2016Hartland, WI
Medtronic Inc., Cardiac Rhythm and Heart Failure
Class IITerminated
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care ...
Reason: Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue with the software that prevents...
Z-2125-2016July 13, 2016Mounds View, MN
ZYTO Technologies, Inc.
Class IITerminated
The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline origin...
Reason: ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.
Z-2121-2016July 13, 2016Lindon, UT
ZYTO Technologies, Inc.
Class IITerminated
The ZYTO Tower is the input device to program the software with various virtual items.
Reason: ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.
Z-2120-2016July 13, 2016Lindon, UT
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by...
Reason: Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appe...
Z-2117-2016July 6, 2016Cleveland, OH
CareFusion 303, Inc.
Class IITerminated
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
Reason: A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alari...
Z-2064-2016July 6, 2016San Diego, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body ...
Reason: Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appea...
Z-2116-2016July 6, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the...
Reason: Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may a...
Z-2118-2016July 6, 2016Cleveland, OH
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
Reason: Software error in previous software versions in which two references for the same image may exist in the database.
Z-2088-2016July 6, 2016Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
Reason: Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by...
Z-2107-2016July 6, 2016Malvern, PA
Fujifilm Medical Systems U.S.A., Inc.
Class IITerminated
Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and F...
Reason: Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
Z-2043-2016June 29, 2016Stamford, CT
Physio-Control, Inc.
Class IITerminated
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4)....
Reason: The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partia...
Z-1993-2016June 22, 2016Redmond, WA
Leica Biosystems Richmond Inc.
Class IIITerminated
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of ...
Reason: An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured s...
Z-1948-2016June 22, 2016Richmond, IL
Med Tec Inc
Class IITerminated
Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041
Reason: When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
Z-1992-2016June 22, 2016Orange City, IA
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VI...
Reason: Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that m...
Z-1913-2016June 15, 2016Rochester, NY
Hospira Inc.
Class IITerminated
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad ...
Reason: Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specifi...
Z-1832-2016June 15, 2016Lake Forest, IL
Philips Healthcare
Class IITerminated
Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan len...
Z-1717-2016June 15, 2016Andover, MA
Sedecal USA, Inc.
Class IITerminated
Sedecal SA Mobile Diagnost w DR x-ray system
Reason: Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type " Newborn" was...
Z-1691-2016June 15, 2016Buffalo Grove, IL
Philips Healthcare
Class IITerminated
Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan len...
Z-1719-2016June 15, 2016Andover, MA
Philips Healthcare
Class IITerminated
Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan len...
Z-1718-2016June 15, 2016Andover, MA
Philips Healthcare
Class IITerminated
Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan len...
Z-1713-2016June 15, 2016Andover, MA
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No...
Reason: Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that m...
Z-1914-2016June 15, 2016Rochester, NY
Philips Healthcare
Class IITerminated
Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan len...
Z-1715-2016June 15, 2016Andover, MA
Philips Healthcare
Class IITerminated
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan len...
Z-1714-2016June 15, 2016Andover, MA
Philips Healthcare
Class IITerminated
Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan len...