Company: Ortho-Clinical Diagnostics.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT The enGenTM Laboratory Automation System consists of 3 main components including Instrument Management Subsystem (Instrument Manager), Automated Track Subsystem (TCAutomation) and Configuration File developed by Ortho-Clinical Diagnostics (OCD). The Instrument Manager is a Windows-based software product that operates on a Pentium-class (or higher) PC processor....Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT 1) ACUSON and SONOLINE Antares and Antares PE ultrasound systems at product versions 4.0 and 5.0 with cardiovascular options installed; ACUSON Antares 4.0 & 5.0: 10032747, 10037592, 10040728; ACUSON Antares PE 4.0 & 5.0: 10032746, 10037591, 10038202, 10040729; SONOLINE Antares 4.0 &...Read More

Company: Philips Medical Systems, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT Extended Brilliance Workstation (EBW) a component of the Computed Tomography The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes; Model #728231. Recall...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system. a) Part No. 081239953, b) SPI Patch, Part No. 08164365. Recall # Z-1834-2011 REASON Software defect problem is repeatable.. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Concord, CA, by letter beginning...Read More

Company: Moog, Inc.Date of Enforcement Report 4/8/2011 Class l: Moog Incannounced today that the Food and Drug Administration (FDA) has classified the voluntary correction of the Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart, and PainSmart IOD as a Class I recall. The affected models were manufactured and updated from May 2007 to February 2011....Read More

Company: QIAGENDate of Enforcement Report 4/6/2011 Class ll: PRODUCT Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation...Read More

Company: Roche Diagnostics Operations, Inc.Date of Enforcement Report 4/6/2011 Class ll: PRODUCT 2. Factor II (prothrombin) G20210A kit, catalog number 03610195001. The Factor II (prothrombin) G20210A kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human factor II gene, from DNA isolated from human whole...Read More

Company: Bio-Rad Laboratories, Inc.Date of Enforcement Report 4/6/2011 Class ll: PRODUCT PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; The Bio-Rad PhD System is an EIA and IFA processing system that consists of a PhD fluid handling station(s) linked to a network computer via an Ethernet hub. The network computer provides worklist generation, data management, data...Read More

Company: Philips Healthcare Inc.Date of Enforcement Report 4/6/2011 Class ll: PRODUCT Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. Used for the termination of ventricular tachycardia and ventricular fibrillation. Recall # Z-1609-2011 REASON Software: EtCO2 and Ventilation Rate...Read More

Company: Hemo Cue, Inc.Date of Enforcement Report 4/6/2011 Class ll: PRODUCT 1) HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level. Recall # Z-1848-2011; 2) HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination. Recall # Z-1849-2011 REASON Incorrect configurations settings in...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/6/2011 Class ll: PRODUCT Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0. Model numbers: 10032747, 10037592, 10040728; SONOLINE Antares: Model numbers: 5936518, 08653771, 10037593; ACUSON Antares PE: Model Numbers: 10032746, 10037591, 10038202, 10040729. Recall # Z-1853-2011 REASON Image captured from the device may...Read More

Company: Baxter Healthcare Corp.Date of Enforcement Report 3/30/2011 Class ll: PRODUCT 1) AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. Recall # Z-1383-2011; 2) AUTOMIX Plus High Speed Compounder...Read More

Company: AGFA Corp.Date of Enforcement Report 3/30/2011 Class ll: PRODUCT Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting. Recall # Z-1434-2011 REASON Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports. RECALLING FIRM/MANUFACTURER Recalling...Read More

Company: Elekta, Inc.Date of Enforcement Report 3/30/2011 Class ll: PRODUCT Elekta Synergy XVI R4.5 Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Recall # Z-1723-2011 REASON If another patient is selected on the imaging system (XVI) release 4.5) during the transmission of end of treatment data from Desktop Pro...Read More

Company: AMO Manufacturing USA, LLC,Date of Enforcement Report 3/30/2011 Class ll: PRODUCT AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog Numbers: 0070-1664, 0070-1649, 0070-1654: Version 3.67 0070-1721: Version 3.671 0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 International version. The WaveScan WaveFront System is a class III accessory...Read More

Company: Siemens Medical SolutionsDate of Enforcement Report 3/30/2011 Class ll: PRODUCT V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac options installed and is at. Multipurpose mobile software controlled diagnostic ultrasound system and on-screen display for thermal and mechanical indices related to bio-effect mechanisms. Its function is to acquire primary...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/30/2011 Class ll: PRODUCT Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is...Read More

Company: Toshiba American Medical Systems Inc.Date of Enforcement Report 3/30/2011 Class ll: PRODUCT SSH-880CV Aplio Artida; System, Diagnostic Ultrasound. Recall # Z-1498-2011 REASON Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues. RECALLING FIRM/MANUFACTURER Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA,...Read More

Company: Hospira IncDate of Enforcement Report 3/23/2011 Class ll: PRODUCT 1) Plum A+ Single Channel Infusion Pumps; the pumps were sold under the following configurations: a) list 11971 b) list 11973 – software version 10.3 c) list 12391 – software version 11.3 d) list 20679 – Hospira MedNet Software e) list 20792 – Driver The...Read More

Company: Straumann Manufacturing IncDate of Enforcement Report 3/16/2011 Class ll: PRODUCT Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10. Recall # Z-1592-2011 REASON Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve. RECALLING FIRM/MANUFACTURER Recalling Firm: Straumann Manufacturing Inc., Andover, MA, by...Read More

Company: AGFA Corp.Date of Enforcement Report 3/23/2011 Class ll: PRODUCT IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8; Catalog Number CM 60+ 00091915. Recall # Z-1676-2011 REASON A discrepancy in the validation testing which resulted in the product not performing as intended. RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corp., Greenville, SC, by...Read More

Company: Bio-Rad Laboratories Inc.Date of Enforcement Report 3/9/2011 Class ll: PRODUCT PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. EIA and IFA processing system that consists of a PhD fluid handling station (s) linked to a network computer via Ethernet hub. The computer provides work list generation, data...Read More

Company: AGFA Corp.Date of Enforcement Report 3/9/2011 Class ll: PRODUCT IMPAX CV Results Manager/Results Manager Administration Tool. The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. The suite is comprised of modular software that runs on industry standard personal computers and servers, utilizing Windows...Read More

Company: Stryker Instruments Division of Stryker Corp.Date of Enforcement Report 3/2/2011 PRODUCT 1) Stryker Navigation System – iNtellect Cranial Software, Part number 6000-650-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization...Read More

Company: Toshiba American Medical Systems IncDate of Enforcement Report 2/23/2011 Class ll: PRODUCT Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) – Whole Body X-Ray CT Scanner. Recall # Z-1257-2011 REASON Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV....Read More

Company: GE Healthcare ITDate of Enforcement Report 2/23/2011 Class ll: PRODUCT GE Centricity Laboratory software; The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. The Centricity Laboratory software is used to...Read More

Company: Hill Rom Inc.Date of Enforcement Report 2/16/2011 Class ll: PRODUCT 1) Hill-Rom TotalCare Bed, P1900. The TotalCare Bed System is intended to provide patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including but not limited to, acute care, including...Read More

Company: Radiometer America Inc. Date of Enforcement Report 2/9/2011 Class ll: PRODUCT ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood. Recall #...Read More

Company: GE Healthcare, LLC.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT GE Healthcare Transport Pro Monitor with the CARESCAPE” Patient Data Module. Recall # Z-0363-2011. REASON Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time...Read More

Company: Varian Medical Systems.Date of Enforcement Report 1/26/2011 Class ll: PRODUCT Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding 8.6.17); Model Number: H48; Radiation Treatment Planning System. Recall Z-0911-2011 REASON Possible incorrect dose calculation: An anomaly in certain Eclipse versions where, under certain specific sequences of user...Read More

Company: Accuray Inc..Date of Enforcement Report 2/9/2011 Class ll: PRODUCT Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1. For the treatment planning and image guided radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the...Read More

Company: Abbott Point of Care Inc.Date of Enforcement Report 2/9/2011 Class ll: PRODUCT i-STAT Level 2 Control Value Assignment Sheets Human Consumption. a) Abbott List Number: 06F13-01; b) Abbott List Number: 025715. Recall # Z-1020-2011. REASON Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain...Read More

Company: Varian Medical SystemsDate of Enforcement Report 2/2/2011 Class ll: PRODUCT 4D Integrated Treatment Console (4DITC); All versions up to and including 8.8.17 Designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while...Read More

Company: Accuray Inc.Date of Enforcement Report 2/9/2011 Class ll: PRODUCT CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5 Medical charged-particle radiation therapy system, intended for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body...Read More

Company: Impac Medical Systems Inc., .Date of Enforcement Report 2/9/2011 Class ll: PRODUCT SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). The intended use of SEQUENCER (a verification system) is to assist in the process of patient treatment on a radiotherapy treatment...Read More

Company: Philips Healthcare Inc.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03. Recall # Z-0414-2011. REASON Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions...Read More

Company: Impac Medical Systems Inc., .Date of Enforcement Report 2/9/2011 Class ll: PRODUCT SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control. Recall # Z-1029-2011. REASON Computer interface is defected. Computer based verification system...Read More

Company:Images, Inc., Date of Enforcement Report 2/9/2011 Class ll: PRODUCT Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect...Read More

Company: Vital Images Inc.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT...Read More

Company: Philips Healthcare Inc.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. The intended use of the Information Center Software is...Read More

Company: Teco Diagnostics.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT 1) Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses...Read More

Company: B. Braun Medical, Inc Date of Enforcement Report 1/24/2010 Class l: PRODUCT Outlook 400ES Safety Infusion System Model number 621-400ES Manufacturing From: May 21, 2009 – June 23, 2009 Distribution From: July, 24, 2009 – December 31, 2009 The recalled products were upgraded from May 4, 2010 – June 21, 2010. Use: The B....Read More

Company: GE Healthcare.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT 1) HiSpeed LXI (2200997). Recall # Z-0744-2011; 2) HiSpeed LX/l (2200997-2). Recall # Z-0745-2011; 3) HiSpeed DX/I (2201000). Z-0746-2011; 4) HiSpeed DX/I (2201000-2). Recall # Z-0747-2011; 5) HiSpeed DX/I (2249696). Recall # Z-0768-2011; 6) HiSpeed DX/I (2249696-2). Recall # Z-0770-2011; 7) HiSpeed FX/I (2200997 with...Read More

Company: McKesson Provider Technologies .Date of Enforcement Report 1/19/2011 Class ll: PRODUCT Horizon Cardiology ECG Management This is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from resting ECG devices. It is also intended to provide analysis or reanalysis or testings ECGs and...Read More

Company: Varian Medical Systems Inc.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX. The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and...Read More

Company: Bunnell Inc.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT 1) One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Rx Only. Recall # Z-0901-2011; 2) One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Rx Only. Recall # Z-0902-2011 REASON Product software coding error may compromise patient safety. RECALLING FIRM/MANUFACTURER Bunnell, Inc.,...Read More

Company: Varian Medical Systems Inc.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT 4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0; Model Number: H51; Distributed and manufactured by: Varian Medical Systems Inc., Palo Alto, CA Intended use: The 4D Integrated Treatment Console function is...Read More

Company: C. R. Bard Inc.Date of Enforcement Report 1/19/2011 Class lll: PRODUCT Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter. Recall # Z-0719-2011 REASON Error can occur...Read More

Company: GE Medical Systems.Date of Enforcement Report 12/22/2010 Class ll: PRODUCT Signa Excite” 1.5 T Magnetic Resonance Systems. Recall # Z-0462-2011p> REASON Signa? MR Excite” 1.5T system containing 11.1_M4_0818.a software, associated with 2D Fast Spin Echo based pulse sequences (2D FSE-XL, 2D FRFSE-XL, 2D FSE-IR, 2D T2FLAIR and 2D T1FLAIR) may experience an image flip...Read More

Company: SCC Soft Computer.Date of Enforcement Report 12/22/2010 Class l: PRODUCT SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. Version 4.0.1.14 Manufactured & Distributed 12/29/2006. Version 4.0.1.15 Manufactured & Distributed 05/02/2007. Version 4.0.1.16 Manufactured & Distributed 08/22/2008. Used in a medical research or clinical laboratory setting by knowledgeable, trained and experienced personnel. Recall # Z-0344-2011...Read More