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recall

Software Recall

REASON Due to a software anomaly, the device acquires data from a slice thicker than intended, and may not be at isocenter. PRODUCT Chemical-Shift Imaging (CSI) Spectroscopy, Model 90LNI. Recall #Z-412-0. CODE Serial Numbers: AF212E, BA109P, BA218P, BA103P, AF165E, AF157EU, BA183P, BA118P, BA182P, BA164D, BA178P, BA114P, BA225P, BA187P, AF113EU, BB104P, BA110P, BA131D, and BA192D. MANUFACTURER...
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1/13/00 Class II PRODUCT Alycon Analyzers, automated chemistry analyzers for in-vitro diagnostic use: a) Alycon Analyzer 300; b) Alycon Analyzer 300i. Recall #Z- 462/463-0. REASON Software program errors cause incorrect association between patient and the patient results. CODE All codes. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Manufacturer, by letter dated January 13, 2000....
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1/8/00 Class III recall PRODUCT Software for Pulmonary Function Testing System: a) BreezePF v3.8 Software, Catalog No. 147536-003; b) BreezePF v3.8A Software, Catalog No. 147570-003. Recall #Z-450/451-0. REASON An anomaly has been discovered in the software that can cause confusion on the selection of which FEV1/FVC ratio is selected for diagnostic reporting. The problem only...
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REASON Software error in Vitros ECi Immunodignostic system. PRODUCT Vitros Immunodiagnostic System, a random access immunodiagnostic analyzer for quantitative and qualitative determination of analytes in human specimens. Recall #Z-360-0. CODE Catalog #8633893, Serial #30000054-30001120. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York. RECALLED BY Manufacturer, by letters dated December 28, 1999, and January 13, 2000, and...
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REASON Software may incorrectly link previous assay results to a different patient ID. PRODUCT Chiron Diagnostics Automated Chemiluminescence System, Model ADVIA:CENTAUR for the quantitative determination of various in vitro diagnostic assays using direct chemiluminescent technology. Recall #Z-358/359-0. CODE Catalog Numbers: 114564, 572561, 572562, 572563, 572564, and 572566. All ADVIA:Centaur Immunoassay Analyzers with software versions 2.01...
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PRODUCT AcQ Plan, 3-D Radiation Therapy Treatment Planning System (software), a software option for the Computed Tomography (CT) Scanners. Recall #Z-300-0. REASON Software anomaly causes the isocenter shift to be labeled incorrectly. CODE All units using the AcQPlan Therapy Planning software version 4.04 are affected. MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio. RECALLED BY...
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PRODUCT Mini-Med MMT-508 Insulin Pump, indicated for the continuous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Recall #Z-288-0. REASON The pump’s software has an error in which the current basal rate profile indicated on the pump display, was a rate programmed for earlier in...
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REASON The software validation of version 4.01R1 a software anomaly was found that affected the proper function of a print option. PRODUCT Vitalcom ST Segment Arrhythmis Detection Software Option, an Optional ECG software feature used in conjunction with the Critikon Observer Central Station on which is installed. There are 12 models or catalog numbers of...
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100 copies. Pato Brachytherapy Treatment Planning System Version 13.2 and higher. Software Implementation Error. Z-039-0/
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PRODUCT Model 250 NeuroCybernetic Prostheses (NCP) Programming Software Versions a) 4/1; b) 4.4, implanted autonomic nerve stimulator for he treatment of epilepsy. REASON The label insert sheets were printed with the incorrect lot number. CODE Lot numbers a) 23952C; b) 26023C, 27137C, 27735C. Recall #Z-570/571-0. MANFACTURER Cyberonics, Inc., Inc., Houston, Texas. RECALLED BY Manufacturer, by...
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IMED Gemini PC-4 Volumetric Infusion Pump and Controller withVersion 1.85 Software: a) PC-4 Infusion Pump, Model 1340, 110 volts; b) PC-4 Infusion Pump, Model 1341, 220 volts. Recall #Z-174/175-0. REASON Due to a software modification, the devices will stop infusing and alarm if the processors receive conflicting or confusing messages. CODE All pumps that carry...
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223 units. 740 ventilator system and ventilator 760 system. Any Ventilator will revision J. software. Software can cause under or over delivery of oxygen. Z-170/171-0
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Nucletron Plato External Beam Planning Radiation Therapy SoftwareV2.1.2 and MLC/Shape Software Module V2.3 Recall #Z-038-0. REASON Coordinates for radiation beam used in therapy are mislabeled in software. CODE Plato RTS software version V2.1.2 used with software module MLC/Shape version V2.3. MANUFACTURER Nucletron BV, The Netherlands. RECALLED BY Nucletron Corporation, Columbia, Maryland, by letter and customer...
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11 systems. Acqplan Radiation Therapy Planning System. A software option for computed tomography scanners. An incorrect calculation of ISO/N dosage may result when changing parameters. Z-1236-9
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7-July-99 Olympus. Class III field correction. EPROM Version 3.00 Software for the Olympus EVIS CV-140 Video System Center. The device has a malfunction due to incorrect coding of the software which can cause the software to overwrite the patient ID number with any comments that are entered by the user.. Z-1227-9IVD
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30-June-99 C30-June-99 Kavo Dental 7 units. Class III. AC powered dental drilling device. Software error may cause unit to shutdown prior to reaching preset torque limit. Z-1215-9
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28-June-99 Quinton Instruments 11 review stations and 7 Sequence NIS stations. Class II.Under certain specific circumstances,sequences of a single plane study, may overlap sequences of bi-plane study when viewing both on the Angiocomm Single Sequence Review Station or the Single Sequence Network Interface Station (NIS). Z-1116/1119-9
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6/22/99 Bayer Corporation 3767 units. Class III Technicon SETpoint Chemistry Calibrator. During review of the value assignment procedure it was learned that the operator manually entered intercept corrected SETpoint values into an Excel spreadsheet rather than letting the spreadsheet calculate the corrections from the true SETpoint. The values that were entered were incorrect and, therefore,...
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6/14/99 Cardiopulmonary Corporation 59 units. Class II Venturi Ventilator with hard drive. User interface software will not load when unit is first powered on. Z-1039-9
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Defense Blood Standard System (DBSS), Blood Bank Software. Recall #B-1094-9. REASON Blood bank computer software does not identify all potential duplicate donor records. CODE Software Versions 3.00 and 3.01. MANUFACTURER Electronic Data Systems (EDS), Herndon, Virginia. RECALLED BY U.S. Department of Defense (DBSS)Composite Health Care System 2, Falls Church, Virginia, by E-mail on June 9...
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Boehringer Mannheim/Hitachi 917 Disk System, a clinical chemistryanalyzer system. Recall #Z-1040-9. REASON The barcode reader can read the wrong sample barcode, mismatch the test results, and report them under the wrong sample. CODE All versions of the disk system software with an updated barcode reader. This includes the system with Serial No. 9715-05 and all...
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5/21/99 VIA Medical Corporation 59 units. Class II VIA Low Volume Mode (LVM) Monitor. The devices has a software problem that can cause the monitor, under unusual circumstances, to display and print a chemistry value from a previous sampling instead of the blood chemistry value from the current sampling. Z-1041-9.
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5/18/99 Cardiopulmonary Corporation 1 unit. Class II Venturi Ventilator Software revision C. Software error may cause ventilator to deliver more than set tidal volume. Z-803-9
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Abbott Alcyon Analyzers with Alcyon System Software Version 1.6.Recall #Z-267-0. REASON The device may give incorrect tests results or reference ranges when printing the “Complete Report (header)”, “Incomplete Report (DRAFT)”, and the “Control Results printout.” CODE List #4E73-04. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Manufacturer, by telephone on May 18 and 19, 1999,...
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4/30/99 Bayer Diagnostics 1000 units. Class II ADVIA 120 Hematology System When running the ADVIA 120 system in the manual mode using the Host Query feature and the timeout is set to 13 seconds, it is possible for the system to report incorrect patient results. The supplemental labeling instructions section of the product labeling instructs...
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4/16/99 Class II Colleague 3 Volumetric Infusion Pump (Triple Channel). Baxter Healthcare 6,992 units. A software communication error occurs predominately when all three channels are in use, causing an alarm codition that will stop the function of all of the channels in use. The pump will alarm appropriately, alerting the user of the failure state....
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All Architect I System Processing Modules with Software Versions1.0 and 1.01. Recall #Z-910-9. REASON The device may report incorrect results for diluted samples; and/or when used with the Laboratory Information System or Host Information Systems, the system may incorrectly associate test results with patient ID or incorrectly associate control results with patient records. CODE List...
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REASON Defective software could result in failure to give warning. CODE Version V1.4 and all previous versions of the software. MANUFACTURER Marquette Medical Systems, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone and letter sent on April 8, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide, Canada, France, Australia, Italy, Sweden. QUANTITY 368 units were distributed.
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Donor Management Information System, Version 1.2. Recall #B-602-9. REASON Y2K defect in the computer software incorrectly calculates the end date of a temporary deferral to be 1900 instead of 2000, and removes the deferral from the database. CODE 11 systems were distributed. MANUFACTURER Information Data Management, Rosemont, Illinois. RECALLED BY Manufacturer, by telephone on January...
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4/6/99 Class II Phillips Medical 1086 units. Integris family of x-ray controls and generators (fluoroscopy,, urology, cardiology). The defect occurs when the system is driven to maximum EER and the source to image receptor distance (SID) is moved toa shorter distance while continuing to make exposures. In this manner of operation, the output may exceed...
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3/29/99 Digisonics Class II OBLink software releases prior to 9.0 39 units. Y2K sofvtware error may produce an incorrect estimated delivery date (EDD). Z-1056-9.
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Eagle 3000 Floorloader Steam Sterilizer. Recall #Z-936-9. REASON There is an error in the control system software, which causes the chamber temperatures to exceed the upper limit. CODE Various serial numbers. MANUFACTURER Steris Corporation, Erie Pennsylvania. RECALLED BY Steris Corporation, Mentor, Ohio, by Customer Notifications on March 10, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada,...
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Philips Medical Sonodiagnost 800, intended for endovaginal biopsy for various gynecologic and obstetric procedures including follicular retrieval, endometrial biopsy, and fluid aspiration of any type in a potentially pregnant patient. Recall #Z-772-9. REASON Software used with Transducer EV7014 incorrectly indicates track of the biopsy needle. CODE All SD800’s with Software versions 2.1. and 2.1.1 used...
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3/5/99 Class II Hewlett Packard 145 units. Software used with transducer EV7014 incorrectly indicates track of biospy needle. Z-772-9
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All IMMULITE 2000 Automated Immunoassay Analyzers with SoftwareVersion 1.1, a clinical automated immunoassay analyzer intended for in-vitro diagnostic use for detection of analytates in human specimens. Recall #Z-909-9. REASON If the initial counts of the reaction tubes are exactly 10,000 cps, this leads to erroneously low calculated results. CODE All serial numbers in commercial distribution...
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Abbott Cell-Dyn 3000 Series Hematology Systems, Cell-Dyn Reticulocyte Reagent, when used in combination with Cell-Dyn 3500 reticulocyte software enables a whole blood specimen to be analyzed for reticulocytes. The Reticulocyte Reagent is intended for in vitro diagnostic use (outside the body). Recall #Z-715-9. REASON These lots may exhibit elevated Reticulocyte results. In some cases, the...
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2/16/99 Class II 128XP Acuson 637 units. Rev 27 software with OB calculations options are affected. Potential error condition related to OB reports printed after diagnosis. Z-787-9
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Solar 7000 and Solar 8000 Patient Monitors with Version 5D Software, used to display physiological data from modules which monitor the patient for ECG, blood pressure, cardiac output, respiration, pulseoximetry, etc. Recall #Z-727/728-9. REASON A software deviation can affect the alarm default settings, which may result in incorrect or missed alarm notification. CODE Solar 7000/8000...
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10-Feb -99 Precision Therapy International. 190 units. Class II. 3-D Imgcomp Utility User Manual Update. Version 2.72b & 3.07d. A design error may leadto a serious miscalculation of radiation dose. Z-1223-9
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2/9/99 Class II Bayer AADVIA120 Hematology System 920 units. The device may give erroneous reslts because of the valve gasket deterioration in the Baso channel check valve, and the software designed will not flag significant discrepancies in the results between the two methodologies at extremely low counts.Z-869/870-9
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2/5/99 Class I recall Marquette Electronics ECG, blood pressure, cariac output, respiraion, pulse oximetry Monitors. 607 new units and 97 update kits. A software deviation can affect alarm default settings, which may result in incorrect or missed alarm notification. Z-727/728-9
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2/1/99 Abbott Alcyon 300 Analyzer (IVD) Possible mixup of patient results. 631 units. Z-617-9
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National Biomedical Computer System, Versions 1.1 to 1.3.2. Recall #B-861-9. REASON Y2K defect in the computer software incorrectly calculates the end date of a temporary deferral to be 1900 instead of 2000, and removes the deferral from the database. CODE Software versions 1.1 to 1.3.2. MANUFACTURER American Red Cross Blood Services, Arlington, Virginia. RECALLED BY...
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Four Recalls of Picker International Nuclear Cameras and imaging systems12/15/98 Prism XPVT 63 units. Unexpected camera movement which requires the operator to power down and reboot with delay in diagnosis. Z-643/650-9 11/18/98 Model 3000 325 units. Unintended motion of gantry during setup. Z-641/642-9 11/17/98 ModelFX AND fx 800 WITH VERSION 8.3.11 software. 70 units. Software...
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12/10/98 Datalink Management System Software Versions 4.1-4.2 Beckman Coulter 248 units. The devices may allow the test results from an associated clinical instrument to be placed under an incorrect sample ID. Z-829-9
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PRODUCTVersion 6A and prior versions of software for Marquette Coherent Digital Telemetry (CDT) LAN Monitoring Systems, a patient monitoring system designed to collect and transmit ECG and other physiological data from ambulatory patients, without the patient being physically connected to a display device. Recall #Z-774-0.
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11/24/98 HMT Medical Technologies Switzerland. Lithotripsy instruments Software versions 3.0 and 1.2. 17 units. Software upgrade yielding error messages and complete lock-up of instruments. Z-680/681
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11/2/98 ACS Centaur Automated Chemiluminescence System 244 units with Software Version 1.2 The device may go into premature ready state with bleach still remaining in the analyzeer lines due to a software error. Z-499-9.
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Software for the Abbott AxSYM System, a fully automated immunoanalyzer. Recall #Z-331-9. REASON Extra assay results from a previous run can appear with new sample results, as well as error messages, due to software defect in the internal result database management. CODE All software versions below 3.03. MANUFACTURER Abbott Laboratories, Irving, Texas. RECALLED BY Abbott...
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9/4/98 Nera Electronics/Baxter Healthcare Flo Gard 8200 Volumetric Infusion Pump: Class II 13 units. Board assemblies had the wrong software version installed on them. The boards have version 2.09 instead of version 2.13. Recall #=-Z-777-8.
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10/1/98 Class II Quinton Q-Cath Hemodynamic Analysis System 81 units. Units with version 4.5 software. Device has potential to display previous patient’s blood pressure. Z-855/859-9
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GE Advantx Vascular Imaging Systems, angiographic X-ray systems: a) GE Advantx Vascular Imaging Systems (DX and DLX) with Stenosis Analysis Software and; b) Cardiac Review Stations (CRS) with Quantitative Analysis Software. Safety Alert #N-002/003-9. REASON When procedures in the Operator Manual for stenosis sizing are not followed each time a time measurement is taken, serious...
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Blood Bank Control Systems. Recall #B-020-0. REASON Computer software contains programming errors that could potentially result in the release of a unit that has not been tested for antibodies. CODE Software versions 4.0 and greater. MANUFACTURER Blood Bank Computer Systems, Kent, Washington. RECALLED BY Manufacturer, by letter dated September 1, 1998. Firm-initiated field correction complete....
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8/12/98 Class II PRODUCT Model No. 250 NeuroCybernetic Prosthesis Programming (NCP) Software, Version 5.0 for use only with the Model No. 100 NCP Pulse Generator and Model No. 200 NCP Programming Wand, an implanted autonomic nerve stimulator implanted for epilepsy. Recall #Z-492-0. REASON The software contains a flaw that reports an inaccurate amount of remaining...
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7/20/98 Hewlett Packard Image Point Ultrasound System Model 2410A used in ultrasound imaging to determine stenosis of the sarotid artery. Software Revisions A.0.0 A.0.1, and A.0.1.2. Class II 441 units. Software overestimates peak blood velocity by 15-25% in some Doppler examinations with the Model 2135A transducer. Recall #=Z-160-8.
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8/10/98 ACS Centaur Automated Chemiluminescence System 29 units with Software Version 1.0-1.2 The test results will be innacurate if the user changes the reporting units and/or slope and intercept for a test. Z-490-9.
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6/25/98 Medtronic 9790C Programmers for Kappa 400 Pacemakekers Model 9952A software: Class II 133 units. Bench testing identified a software anomaly that could result in the delivery of an unitended pacing mode or pacing interval. Recall #=Z-715-8
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6/24/98 Beckman/Coulter Access Immunochemistry Set 81500 Software versions 3.22 and 3.23: Class II 1296 units. Sofware anomaly in these versions may allow test results to be posted to a different patient sample number. Recall #=Z-786/787-8.
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6/17/98 Lifescan Surestep Blood Glucose Monitoring System (Meter of home use) Changed to Class I 727,004 units The meters may give an Er 1 (Error 1)message if a patient’s blood glucose is 500 mg/dL or greater.
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Resuscitaire Radiant Warmer, Infant Radiant Warmer: a) Resuscitaire Radiant Warmer, Model RW81; b) Resuscitaire Radiant Warmer, Model RW82; c) Resuscitaire Radiant Warmer, Model RW82VHA; d) Resuscitaire Radiant Warmer, Model WMRW82; e) Resuscitaire Radiant Warmer, Model WBR 81; f) Resuscitaire Radiant Warmer, Model WBR82. Recall #Z-292/297-9. REASON The device fails to control heater power due to...
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CIBA Corning ACS 180 Plus Analyzers, used for numerous assays. Recall #Z-359-9. REASON A software error for Troponin I analysis caused erroneous results. CODE All ACS 180 Plus Analyzers with test definition AL software version. MANUFACTURER Chiron Diagnostics Corporation, Oberlin, Ohio. RECALLED BY Manufacturer, by letter/technical bulletin on June 9, 1998. Firm-initiated field correction complete....
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Venturi Ventilator, provides a software that continuously adaptsto the patient’s changing breathing demands and assures ventilation at the lowest pressure. Recall #Z-803-9. REASON Software error may cause ventilator to deliver more than set tidal volume. CODE Venturi Ventilator with Software Revision C. Serial #970222. MANUFACTURER Cardiopulmonary Corporation, Milford, Connecticut. RECALLED BY Manufacturer, by letter on...
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Information Management System for Mammography Practices. Recall #Z-187-9. REASON The software was manufactured with methods that resulted in defective information being provided to the physician, and therefore, the patients with positive mammograms may not follow-up with a biopsy exam. CODE All copies of Mammoworks Version 2.6. MANUFACTURER Lumisys, Inc., (formerly Compurad), Tucson, Arizona. RECALLED BY...
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ACS:Centaur Automated Chemiluminescence System, used to conduct various laboratory diagnostictests. Recall #Z-363-9. REASON Software errors for V1.0 which could lead to erroneous test results. CODE All lot numbers for the ACS Centaur. MANUFACTURER Chiron Diagnostics Corporation, Oberlin, Ohio. RECALLED BY Manufacturer, by fax dated March 25, 1998. Firm-initiated field correction complete. DISTRIBUTION Germany and Italy....
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3/17/98 Recon Rx neurological biofeedback monitoring1762 units Rx unit were not functioning correctly. Obsolete version 3.01 software had been installed in the units.
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Venturi Ventilator, used to provide a software that continouslyadapts to the patient’s changing breathing demands and assures ventilation at the lowest pressure. The display monitor provides pertient patient parameters and waveforms. Recall #Z-802-9. REASON Display monitor may go blank due to faulty inverter. CODE Serial numbers: 970192, 970190, 970154, 970164, 970169, 970172, 970138, 970161, 970163,...
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CIBA Corning ACS:180 SE Analyzer, used to conduct various laboratory diagnostic tests. Recall#Z-369-9. REASON Software error causes 16 different assays to not calculate SI units correctly. CODE All lot numbers for ACS 180 SE Analyzers. MANUFACTURER Chiron Diagnostics Corporation, Oberlin, Ohio. RECALLED BY Manufacturer, by fax on November 25, 1997. Firm-initiated field correction complete. DISTRIBUTION...
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9/30/97 EZ-Flow 480 Ambulatory Infusion Pump 1058 devices. Defective software may cause over infusion when using the PCA mode. 1/9/98 confirmed a patient death due to a software logic error related to use in the patient controlled analgesia (PCA) mode caused the lethal dose of morphine sulfate. Two non-fatal incidents in 1996 also occurred.
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7/7/97 Solar 7000/8000 Patient Monitors with Software Revision 4A783 units. A software defect is causing incorrect waveform data.
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McGaw Stratus Ambulatory Infusion System Model 550 and Alphamed EZ Pump, Model 550 withSoftware Version 2.32.00/2.42.01. Recall #Z-188-9. REASON The pump could under infuse or blood could back up into IV lines when the pumps are running at a slow flow rate with a large infusion set. CODE Serial Numbers: P61145, P71108, P71115, P71125, P71130,...
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6/5/97 HP M1026a Anesthetic Gas Analyzer with O2 sensor2,284 units. The units may display innacurrate oxygen reading due to software problem.
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3/13/97 Sulzer Intermedics Marathon SR & DR Pacemakers 3300 units RX 5000 Software Operating System A software condition caused the parameters of the 2 pacemakers to become reversed. That is, the software cannot distinguish Marathon DR (dual chamber) from Marathon SR (single-chamber) USER PRESET values; whichever values were most recently stored will be recalled.
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1/10/97 Quinton Instrument Stress Test Monitors – 3 models ~7000units affected.A software anomaly could cause their treadmills to erroneously increase or decrease in speed and/or grade when the “Stop EXER” key is pressed at the end of a stage.
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9/27/96 Radiation Oncology Computer Systems (ROCS) Treatment Planning System Software Version 5.0.x. An error occurs when using this software version for brachytherapy dose estimations for user specified calculation points for re-oriented linear sources.
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CIBA Corning Acs:180 and ACS:180 Plus Analyzers, used to conduct various laboratory diagnostictests. Recall #Z-368-9. REASON Due to a software error, the ACS Folate and ACS T-Uptake assays may run without the required conditioning solution. As a result, the test results may be outside of the system requirements. CODE All serial numbers for the ACS...
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2/14/96 ADAC Laboratories Pinnacle Radiation Therapy Planning Software 83 tapes recalled Due to a software problem, the wedge scatter fields will be calculated incorrectly if the wedge filter is not square. Software version 2.1F
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:3/26/2014 Class lI: PRODUCT syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 Recall Number Z-1216-2014 REASON Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one...
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