Company:Siemens Medical Solutions Date of Enforcement Report:4/6/2007 Class:ll PRODUCT Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system, Recall # Z-0652-2007 REASON The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due...Read More

Company:GE OEC Medical Systems,Inc Date of Enforcement Report:4/6/2007 Class:ll PRODUCT InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body), Recall # Z-0704-2007 REASON Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software. CODE InstaTrak 3500 Plus...Read More

Company:bioMerieux, Inc., Date of Enforcement Report:3/28/2007 Class:ll PRODUCT BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, Recall # Z-0644-2007 REASON Bottle data is not sent to BacT/ALERT 3D instrument. CODE All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software). RECALLING FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC, by letter on December...Read More

Company:Stentor Inc Date of Enforcement Report:3/21/2007 Class:ll PRODUCT The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data throughout a clinical environment, Recall # Z-0616-2007 REASON A defect may cause patient image orientation markers to be incorrectly labeled on...Read More

Company:Beckman Coulter, Inc. Date of Enforcement Report:3/14/2007 Class:ll PRODUCT Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5), Recall # Z-0566-2007 REASON There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the...Read More

Company:Siemens Medical Solutions USA, Inc., Date of Enforcement Report:2/28/2007 Class:ll PRODUCT a) Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; part number 08717741, Recall # Z-0548-2007; b) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System with a Pinhole Collimator, Recall # Z-0549-2007 REASON Symbia systems, running...Read More

Company:Cyberonics, Incl Date of Enforcement Report:1/31/2007 Class:ll PRODUCT a) Cyberonics VNS Therapy System, Model 250-‘HAND HELD’ programming software v6.1, v6.1.7, v7.0 and v7.1.3, Recall # Z-0341-2007; b) Handhelds-Cyberonics VNS Therapy System, Model 2500-‘Handhelds’ preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3, Recall # Z-0342-2007 REASON During programming, pulse generator may be inadvertently set to...Read More

Company:Terumo Advanced Perfusion System 1 Date of Enforcement Report:2/7/2007 Class:ll PRODUCT Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046, Recall # Z-0381-2007 REASON Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and...Read More

Company:GE Healthcare Integrated IT Solution Date of Enforcement Report:1/31/2007 Class:ll PRODUCT GE Centricity PACS RA 1000 Workstation; for diagnostic image analysis; Software versions 2.1.XX. and 3.0.XX. used in combination with the GE Senographe 2000D, Senographe DS or Senographe Essential, Recall # Z-0373-2007 REASON The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display...Read More

Company:Beckman Coulter, Inc. Date of Enforcement Report:1/10/2007 Class:ll PRODUCT Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers, Recall # Z-0471-2007 REASON The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may...Read More

Company:Beckman Coulter Inc., Date of Enforcement Report:1/4/2007 Class:ll PRODUCT LFC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit, Recall # Z-0317-2007 REASON The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog...Read More

Company:Terumo Cardiovascular Systems Corp Date of Enforcement Report:1/5/2007 Class:ll PRODUCT a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763, Recall # Z-0314-2007; b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within...Read More

Company:Medtronic Emergency Response Systems, Inc., Date of Enforcement Report:12/27/2006 Class:ll PRODUCT LIFEPAK 20 automatic external defibrillator, Recall # Z-0295-2007 REASON LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power. CODE Devices with software version -028, -030, -032, and -038. RECALLING FIRM/MANUFACTURER Medtronic Emergency Response Systems, Inc., Redmond...Read More

Company:St Jude Medical Date of Enforcement Report:12/27/2006 Class:ll PRODUCT a) St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510, Recall # Z-0296-2007; b) St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650, Recall # Z-...Read More

Company:Data Innovations, Inc. Date of Enforcement Report:12/6/2006 Class:ll PRODUCT a) Roche Modular Drive (rchmdlri), analytical laboratory data interface, Recall # Z-0223-2007; b) Roche Cobas driver (rchcob6i), analytical laboratory data interface, Recall # Z-0224-2007 REASON Software of modular driver may incorrectly report patient results as Quality Control Results. CODE a) Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and...Read More

Company:AGFA Corp., Date of Enforcement Report:11/29/2006 Class:ll PRODUCT CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405), Recall # Z-0219-2007 REASON Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on...Read More

Company: Beckman Coulter Inc Date of Enforcement Report:11/29/2006 Class:ll PRODUCT Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1, Recall # Z-0197-2007 REASON Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube...Read More

Company:Data Innovations, Inc., Date of Enforcement Report:11/22/2006 Class:ll PRODUCT Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R), Recall # Z-0167-2007 REASON Patient results may be associated with an incorrect specimen. CODE Software Versions: 8:00, 8.01, 8.02, 8.03 or 8..04 RECALLING FIRM/MANUFACTURER Data Innovations, Inc., South...Read More

/Docs/GERecallLetter9800_8800_6800Nov2007.pdfRead More

CompanyGuidant Corporation Date of Enforcement Report:11/1/2006 Class:ll PRODUCT Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators, Recall # Z-0002-2007 REASON Final software load did not occur prior to shipment of select programmers. CODE Serial numbers: 051089, 051449, 055130, 056463,...Read More

Company:AGFA Corp., Date of Enforcement Report:10/18/2006 Class:ll PRODUCT CR DX-S, Image Intensified Fluoroscopic X-ray system, Recall # Z-0031-2007 REASON Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss. CODE Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below. RECALLING FIRM/MANUFACTURER Recalling...Read More

Company: Hitachi Medical Systems America Inc. Date of Enforcement Report:10/18/2006 Class:ll PRODUCT MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J, Recall # Z-0029-2007 REASON Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol,...Read More

Company: GE OEC Medical Systems, Inc. Date of Enforcement Report:10/11/2006 Class:ll PRODUCT a) GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, Recall # Z-1301-06; b) GE OEC 9800 Fluoro C-Arm X-ray system, Recall # Z-1302-06; c) RUS Tool Version Software, Recall # Z-1303-06 REASON X-ray systems could provide output which exceeds the 20 R/minute...Read More

/Docs/GEadvisory_notice_OEC_InstaTRAK_3500_15037.pdfRead More

Company: Philips Medical Systems Date of Enforcement Report:9/20/2006 Class:ll PRODUCT IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A, Recall # Z-1487-06 REASON Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached . CODE M3001A options A01, A01C06, A01C12, and A01C18 with serial number prefix DE512 and MMS...Read More

Company:Beckman Coulter Inc., Brea, CA Date of Enforcement Report:9/13/2006 Class:ll PRODUCT FP1000 Cell Preparation System Part Number 624922, Recall # Z-1466-06 REASON During the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Cell Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack...Read More

Company: BEckman Coulter Inc. Date of Enforcement Report:9/6/2006 Class:ll PRODUCT UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems, Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4, Recall # Z-1440-6 REASON Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly...Read More

Company:Bayer Healthcare, LLC Date of Enforcement Report:9/6/2006 Class:ll PRODUCT ADVIA 2120 systems –Automated Complete Blood Cell and Differential Cell Counter, Recall # Z-1376-06 REASON The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an abnormal baso...Read More

Company:Alaris Products, FDA News FOR IMMEDIATE RELEASE P06-119 August 28, 2006 Media Inquiries: Catherine McDermott, 301-827-6242 Consumer Inquiries: 888-INFO-FDA United States Marshals Seize Defective Infusion Pumps Made by Alaris Products Pumps Can Deliver Excess Medication and Harm Patients At the request of the U.S. Food and Drug Administration (FDA), the U.S. District Court for the...Read More

Company: Varian Medical Systems Date of Enforcement Report:8/23/2006 Class:ll PRODUCT a) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row, part number GM11005400, for the GammaMed model 12i radionuclide applicator system, Recall # Z-1398-06; b) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed...Read More

Company: Immucor, Inc., Date of Enforcement Report:8/23/2006 Class:ll PRODUCT Galileo Automated Blood Bank Analyzer (in-vitro diagnosis testing of human blood using a microplate platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red cell antibodies and compatibility testing), Recall #B-1645-6 REASON Blood Bank Analyzer, with a software glitch, was distributed. CODE atalog...Read More

Company:ABX Diagnostics Date of Enforcement Report:8/23/2006 Class:lll PRODUCT ABX Pentra 120, 120R, 120DX, automated hematology analyzer, Recall # Z-1334-06 REASON Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.. CODE All serial numbers, all software versions. RECALLING FIRM/MANUFACTURER Recalling Firm: ABX Diagnostics, Inc., Irvine,...Read More

Company:Radiometer America Inc. Date of Enforcement Report:8/16/2006 Class:lI PRODUCT a) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series, Recall # Z-1317-06; b) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series, Recall # Z-1318-06 REASON Software defect. pO2 and pCO2 sample test results run on the firm’s ABL700/800 Series Blood Gas Analyzers...Read More

Company: Radiometer America, Inc, Date of Enforcement Report:8/16/2006 Class:lIl PRODUCT ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21, Recall # Z-1325-06 REASON ABL800 Series Blood Gas Analyzer became inoperable when the restore default setup button was touched.. CODE Software Versions 5.21 i.e. ABL8xx 754R00xx N0xx RECALLING FIRM/MANUFACTURER Recalling Firm: Radiometer America, Inc., Westlake,...Read More

Company: Edwards Lifesciences Llc, Date of Enforcement Report:8/23/2006 Class:ll PRODUCT Edwards Vigilance Monitors (Formerly Baxter Vigilance Monitors). Patient monitor which measures cardiac output. Models: VG, VGS, VGS1, VGS2, VG2, & IVM, Recall # Z-1310-06 REASON Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the...Read More

Company: AGFA Corp., Date of Enforcement Report:8/23/2006 Class:lI PRODUCT Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators, Recall # Z-1375-06. REASON A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators. CODE...Read More

Company: Kensey Nash Corp., Date of Enforcement Report:8/9/2006 Class:ll PRODUCT TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach, Recall # Z-1305-06 REASON Alarm activation-A priming issue involving the flow control unit due to...Read More

Company: Beckman Coulter, Inc Date of Enforcement Report:8/2/2006 Class:lI PRODUCT Beckman Coulter Cytomics FC 500 Flow Cytometry System, Part Numbers 626553 (TN; FC500 with UPS), 6605627 (TN; 5 CLR, FC500 (100V), 6605628 (TN; 5CLR, FC500 (120V), 6605629 (TN; 5 CLR, FC500 (220V), 6605630 (TN; 5 CLR, FC500 (240V) with CXP Software Versions 2.0 and 2.1,...Read More

Company: bioMerieux, Inc, Date of Enforcement Report:8/2/2006 Class:lI PRODUCT a) Hamilton brand RAPHAEL Ventilator (Software Version 2.2x), Recall # Z-1249-06; b) Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS), Recall # Z-1250-06; c) Hamilton brand RAPHAEL Color Ventilator (Software Version 2.2xC, 2.2xCU), Recall # Z-1251-06 REASON Alarm Failure — Following an oxygen cell calibration, the...Read More

Company: Varian Medical Systems, Date of Enforcement Report:8/2/2006 Class:lI PRODUCT a) Gamma Win software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus radionuclide applicator system, for radiation therapy, Recall # Z-1268-06; b) Gamma Win software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus 3/24 radionuclide applicator system,...Read More

Company: SCC Soft Computer, Date of Enforcement Report:8/2/2006 Class:lI PRODUCT SoftPath ASXII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinical documentation and data processing, Recall # Z-1243-06 REASON Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a...Read More

Company: AGFA Corp., Date of Enforcement Report:8/2/2006 Class:lIl PRODUCT IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images, Recall # Z-1256-06 REASON Possible corrupted image appearing after System Start. CODE All Impax 4.5 sites running Solaris 9 (Sun OS 5.9) that do not have Sun Patch ID 118305-08...Read More

Company: Radiometer America, Inc., Date of Enforcement Report:8/2/2006 Class:lI PRODUCT Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic, Model 914-317 Radiance Basic Kit, Recall # Z-1262-06 REASON Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the...Read More

Company: Beckman Coulter, Inc., Date of Enforcement Report:7/26/2006 Class:lI PRODUCT Coulter LH500 Hematology Analyzer; Part Numbers 178832, 178833 and 178834, Recall # Z-1245-06 REASON Beckman has confirmed that erroneous results could be reported when the workstation data base crashes. CODE All software versions RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter sent...Read More

Company: Siemens Medical Solutions, USA, IncDate of Enforcement Report:7/26/2006 Class:lIl PRODUCTKinetDx 4.0 Ultrasound Image Management System, Recall # Z-1235-06 REASON The cardiologist’s report comments may not be retained by the system due to a software bug.. CODE All units with software versions 4.0 and 4.1 RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Solutions, USA, Inc., Ann...Read More

Company: General Electric Med. Sys. Date of Enforcement Report:7/12/2006 Class:lIl PRODUCT Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. The device is a general-purpose diagnostic ultrasound system, Recall # Z-1172-06 REASON In the cardiac measurement section of the device the calculation of the...Read More

Company: Abbott Laboratories, Date of Enforcement Report:7/12/2006 Class:lIl PRODUCT ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3, Recall # Z-860-06 REASON The 30-day onboard storage information is not included in the...Read More

Company: bioMerieux, Inc, Date of Enforcement Report:7/8/2006 Class:lI PRODUCT OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D. Recall # Z-1161-06 REASON Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle IDs. CODE Software...Read More

Company: Alcon Laboratories, Inc., Date of Enforcement Report:6/28/2006 Class:lI PRODUCT LADARVision Excimer Laser System, Recall # Z-1147-06 REASON A software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of this feature after alignment of the horizontal reference line will negate compensation for cyclotorsion on Custom...Read More

Company: Hitachi Medical Systems America, Inc., Date of Enforcement Report:6/21/2006 Class:lI PRODUCT Altaire Nuclear Magnetic Resonance Imaging Device Systems, Recall # Z-1104-06 REASON Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result...Read More