Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
Reason: Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurement...
Z-2123-2017May 31, 2017Hartland, WI
Thoratec Corporation
Class ITerminated
HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricul...
Reason: St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easi...
Z-2051-2017May 31, 2017Pleasanton, CA
Ortho-Clinical Diagnostics
Class IITerminated
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
Reason: Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-assoc...
Z-2077-2017May 24, 2017Rochester, NY
Orthosoft, Inc. dba Zimmer CAS
Class IIITerminated
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Reason: ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2...
Z-2075-2017May 24, 2017Montreal
Orthosoft, Inc. dba Zimmer CAS
Class IITerminated
Navitrack System - OS Knee Universal, Stereotaxic instrument
Reason: Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software iss...
Z-2076-2017May 24, 2017Montreal
Mobius Medical Systems, LP
Class IITerminated
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation o...
Reason: Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam customization, and may lead to a discrepancy in dose calculation between this versio...
Z-2100-2017May 24, 2017Houston, TX
Med-Hot Thermal Imaging, Inc.
Class IITerminated
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing ...
Reason: Indications for use are not cleared or approved for market in the U.S.
Z-2057-2017May 17, 2017Lakeland, FL
Roche Diagnostics Corporation
Class IITerminated
Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 ...
Reason: Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and lead to a disturbance of the sample liquid level detection (LLD). When disturbance o...
Z-2049-2017May 17, 2017Indianapolis, IN
Siemens Healthcare Diagnostics Inc
Class IITerminated
RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, an...
Reason: Potential Patient Demographic Error with Blank Patient ID Field
Z-2040-2017May 17, 2017Norwood, MA
Medtronic Inc.
Class IITerminated
MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
Reason: Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump...
Z-1890-2017May 10, 2017Northridge, CA
Beckman Coulter Inc.
Class IITerminated
AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications usin...
Reason: Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.
Z-2035-2017May 10, 2017Brea, CA
Siemens Medical Solutions USA, Inc.
Class IITerminated
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S20...
Reason: When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the t...
Z-1875-2017May 3, 2017Mountain View, CA
Orthosoft, Inc. dba Zimmer CAS
Class IITerminated
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Reason: Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.
Z-1881-2017May 3, 2017Montreal, N/A
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis zee, Angiographic x-ray system
Reason: Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube ...
Z-1824-2017April 26, 2017Malvern, PA
BD LIFE SCIENCES
Class IITerminated
Software version 4.44A utilized on the BD MAX System
Reason: The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP)...
Z-1864-2017April 26, 2017Sparks Glencoe, MD
Bd Diagnostic
Class IITerminated
BD Viper LT software, version 3.00H
Reason: BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease...
Z-1866-2017April 26, 2017Sparks, MD
Roche Diagnostics Corporation
Class IITerminated
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Reason: "Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) m...
Z-1763-2017April 19, 2017Indianapolis, IN
Intuitive Surgical, Inc.
Class IITerminated
da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irr...
Reason: Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion...
Z-1819-2017April 19, 2017Sunnyvale, CA
Merge Healthcare, Inc.
Class IITerminated
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheteriz...
Reason: Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
Z-1778-2017April 19, 2017Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Reason: An error message can occur resulting in the prior studies being unavailable for viewing.
Z-1762-2017April 19, 2017Hartland, WI
Roche Diagnostics Corporation
Class IITerminated
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Reason: Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (BRF) mo...
Z-1764-2017April 19, 2017Indianapolis, IN
RAYSEARCH LABORATORIES AB
Class IITerminated
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatme...
Reason: An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured ...
Z-1815-2017April 19, 2017Stockholm, N/A
Zimmer Biomet, Inc.
Class IITerminated
MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instrument...
Reason: Unapproved change made by the supplier.
Z-1755-2017April 19, 2017Warsaw, IN
PerkinElmer Life and Analytical Sciences, Wallac, OY
Class IITerminated
Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
Reason: Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Z-1761-2017April 19, 2017Turku, N/A
Philips Visicu
Class IITerminated
eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological dev...
Reason: eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological device...