The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.
Reason: The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
Z-1518-2015April 29, 2015Lake Forest, IL
Thermedx LLC
Class IITerminated
Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, ...
Reason: To correct software bugs that could affect the ability to accurately measure fluid deficit.
Z-1463-2015April 29, 2015Solon, OH
Baxter Healthcare Corp
Class IITerminated
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with M...
Reason: Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the near...
Z-1451-2015April 22, 2015Deerfield, IL
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry anal...
Reason: Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1.0.2. The system may cause samples to remain in an Inprocess state. Test result...
Reason: Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.
Z-1359-2015April 8, 2015Cleveland, OH
Siemens Medical Solutions USA, Inc
Class IITerminated
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-s...
Reason: The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation ...
Z-1308-2015April 1, 2015Malvern, PA
GE Healthcare
Class IITerminated
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Disc...
Reason: GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
Z-1305-2015April 1, 2015Waukesha, WI
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, r...
Reason: An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error dep...
Z-1310-2015April 1, 2015Stockholm
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
Reason: There is a potential safety risk when using LANTIS server software with operating systems with which it has not been validated or released which can lead to an incorrect treatment ...
Z-1282-2015March 25, 2015Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of...
Reason: There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
Z-0984-2015March 25, 2015Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed tomography is to produce cross-sect...
Reason: Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system start-up behavior and resuming, ...
Z-1267-2015March 18, 2015Malvern, PA
Medtronic MiniMed Inc.
Class IIITerminated
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blo...
Reason: The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded f...
Z-1228-2015March 11, 2015Northridge, CA
INO Therapeutics (dba Ikaria)
Class IITerminated
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Reason: Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the dis...
Z-1223-2015March 11, 2015Madison, WI
Philips Medical Systems, Inc.
Class IITerminated
Philips Medical System Allura Xper X-Ray Angiographic
Reason: In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.
Z-1120-2015March 11, 2015Andover, MA
iCAD, Inc.
Class IITerminated
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Reason: A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming radiographs are not taken and properly evaluated, biopsy site mislocat...
Z-1243-2015March 11, 2015Nashua, NH
Iba Dosimetry Gmbh
Class IITerminated
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Reason: Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc l...
Z-1212-2015March 4, 2015Schwarzenbruck, N/A
Natus Medical Incorporated
Class IITerminated
EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction...
Reason: Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do ...
Z-1068-2015February 18, 2015Oakville, Ontario
Natus Medical Incorporated
Class IITerminated
EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulat...
Reason: Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do ...
Reason: Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.
Z-1070-2015February 18, 2015Foster City, CA
Carl Zeiss Meditec AG
Class IITerminated
FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000...
Reason: Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data.
Z-1049-2015February 11, 2015Jena, N/A
GE Healthcare
Class IITerminated
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconn...
Reason: A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
Z-0955-2015February 4, 2015Waukesha, WI
Philips Medical Systems (Cleveland) Inc
Class IITerminated
BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
Reason: Unintended detector and gantry movement due to software issues.
Z-1011-2015February 4, 2015Cleveland, OH
Maquet Medical Systems USA
Class IITerminated
TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two ...
Reason: The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower Leg Up and Upper Leg Down are switched in the software for the integratio...
Z-0993-2015January 28, 2015Wayne, NJ
Ortho-Clinical Diagnostics
Class IIITerminated
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measur...
Reason: Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
Z-1004-2015January 28, 2015Rochester, NY
Siemens Medical Solutions USA, Inc
Class IITerminated
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max ...
Reason: Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associate...