UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, sem...
Reason: The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause err...
Z-2258-2012August 29, 2012Brea, CA
Sunquest Information Systems, Inc.
Class IIITerminated
Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
Reason: Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only wh...
Z-2243-2012August 29, 2012Tucson, AZ
Beckman Coulter Inc.
Class IITerminated
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in...
Reason: The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause err...
Z-2259-2012August 29, 2012Brea, CA
Hitachi Medical Systems America Inc
Class IITerminated
Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician wi...
Reason: Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new...
Z-2254-2012August 29, 2012Twinsburg, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken a...
Reason: 1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanni...
Z-2223-2012August 29, 2012Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a dia...
Reason: Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Supplier of the UPS, Chloride/Eme...
Z-2239-2012August 29, 2012Cleveland, OH
Philips Healthcare Inc.
Class IITerminated
Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
Reason: Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors...
Z-2208-2012August 22, 2012Andover, MA
GE Healthcare, LLC
Class IITerminated
GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Vol...
Reason: GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking y...
Z-2203-2012August 22, 2012Waukesha, WI
Radiometer America Inc
Class IITerminated
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Reason: A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to...
Z-2164-2012August 15, 2012Westlake, OH
Varian Medical Systems, Inc. Oncology Systems
Class IITerminated
Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medi...
Reason: A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported.
Z-2153-2012August 15, 2012Palo Alto, CA
Radiometer America Inc
Class IITerminated
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+,...
Reason: A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to...
Z-2163-2012August 15, 2012Westlake, OH
Radiometer America Inc
Class IITerminated
The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu,...
Reason: A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to...
Z-2162-2012August 15, 2012Westlake, OH
Smiths Medical ASD, Inc.
Class ITerminated
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for ...
Reason: Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. ...
Z-2107-2012August 8, 2012Saint Paul, MN
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Reason: software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verific...
Z-2066-2012August 1, 2012Rochester, NY
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens syngo.plaza. Radiological image processing system
Reason: Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are...
Z-2078-2012August 1, 2012Malvern, PA
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Reason: software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verific...
Z-2068-2012August 1, 2012Rochester, NY
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Reason: software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verific...
Z-2067-2012August 1, 2012Rochester, NY
Sigma
Class IIITerminated
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
Reason: Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library t...
Z-2030-2012July 25, 2012Medina, NY
GE Healthcare, LLC
Class IITerminated
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
Reason: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related to Visual indication as mandate...
Z-1993-2012July 25, 2012Waukesha, WI
Hitachi Medical Systems America Inc
Class IITerminated
Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helic...
Reason: Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstr...
Z-2037-2012July 25, 2012Twinsburg, OH
B. Braun Medical, Inc.
Class ITerminated
Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatri...
Reason: Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserte...
Z-1992-2012July 25, 2012Allentown, PA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
Reason: Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves th...
Z-1988-2012July 18, 2012Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise...
Reason: In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode "edit contour" tool, the measurements are not recalculated causing...
Z-2000-2012July 18, 2012Cleveland, OH
GE Healthcare, LLC
Class IITerminated
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provid...
Reason: GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewe...
Z-1960-2012July 18, 2012Waukesha, WI
Philips Healthcare Inc.
Class IITerminated
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is fo...
Reason: Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG