Tag

recall

Software Recall

Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems._x000D_ _x000D_ Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. Recall Number Z-0800-2014 REASON An overflow flag //// is displayed in the result column for a test when the...
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Company: GE Healthcare It Date of Enforcement Report: 2/5/2014 Class lI: PRODUCT Centricity PACS System versions 3.X and higher and 4.X and higher_x000D_ Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It...
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Company: Elekta inc. Date of Enforcement Report:1/29/2014 Class lI: PRODUCT XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose...
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Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 1/29/2014 Class lI: PRODUCT Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. Recall Number Z-0800-2014 REASON An overflow flag //// is displayed in the result column for a test when the algorithm...
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Company: GE Healthcare LLC Date of Enforcement Report: 1/22/2014 Class lI: PRODUCT GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698. Recall Number Z-0725-2014 REASON There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima...
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Company: GE Healthcare It Date of Enforcement Report: 1/22/2014 Class lI: PRODUCT Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT. Two and three dimensional image review,...
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Company: Draeger Medical Systems, Inc. . Date of Enforcement Report:1/22/2014 Class lI: PRODUCT Draeger Infinity Acute Care System Monitoring Solution Recall Number Z-0714-2014 REASON After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate...
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Company: Carestream Health Inc. Date of Enforcement Report:1/15/2014 Class lI: PRODUCT Carestream DRX-Revolution Mobile X-Ray System — Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 — The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products...
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Company: EOS Imaging Date of Enforcement Report:1/15/2014 Class lI: PRODUCT EOS System X- ray beam Digital radiography system used in general radiographic examinations. Recall Number Z-0529-2014 REASON EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from...
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Company: Covidien. Date of Enforcement Report:1/15/2014 Class lI: PRODUCT Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients. Recall Number Z-0611-2014 REASON Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions...
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Company: Welch Allyn Protocol, Inc Date of Enforcement Report:1/15/2014 Class lI: PRODUCT The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate...
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Company:Covodien. Date of Enforcement Report:1/9/2014 Class l: PRODUCT Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG._x000D_ _x000D_ The intended use of the product is to provide mechanical ventilation to patients. Recall Number Z-0611-2014 REASON Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop...
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Company: GE Healthcare It Date of Enforcement Report: 1/8/2014 Class lI: PRODUCT The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially...
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Company: Nipro Diganostics Date of Enforcement Report:1/6/2014 Class lI: PRODUCT TRUEbalance and TRUEtrack blood glucose meters distributed in the U.S., Europe, Asia and Canada, the company said Thursday. REASON The affected meters ? 501 TRUEbalance and 105 TRUEtrack ? may have a flaw in the factory-set unit of measure that would cause them to measure...
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Company: Varian Medical Systems, Inc. Date of Enforcement Report:1/1/2014 Class lI: PRODUCT Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation. Recall Number Z-0552-2014 REASON An anomaly...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report:1/1/2014 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in...
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Company:CareFusion 303, Inc.. Date of Enforcement Report:1/1/2014 Class l: PRODUCT Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia)...
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Company: Data Innovations, Inc. Date of Enforcement Report:1/1/2014 Class lI: PRODUCT Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004 Recall Number Z-0571-2014 REASON When connected to the Sysmex UF-100, the...
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Company: Mckesson Information Solutions LLC Date of Enforcement Report:1/1/2014 Class lI: PRODUCT McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). Recall Number Z-0556-2014 REASON When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy information for the second patient record. RECALLING FIRM/MANUFACTURER Mckesson...
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Company: EOS Imaging Date of Enforcement Report:1/1/2014 Class lI: PRODUCT steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images. Recall Number Z-0580-2014 REASON Error copying information to...
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Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report:12/25/2013 Class lI: PRODUCT MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure...
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Company: Beckman Coulter Inc. Date of Enforcement Report:12/25/2013 Class lI: PRODUCT Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Recall Number Z-0519-2014 REASON Beckman Coulter is initiating a recall for the...
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Company: SCC Soft Computer Date of Enforcement Report:12/18/2013 Class lI: PRODUCT SoftBank II versions: 23.1, 23.2, 25.0, 25.1, 25.2, and 25.3. When used with SoftScape GUI 1.2.0.x and 1.3.0.x Recall Number B-0216-14 REASON Blood Bank software with a defect or glitch, was distributed.. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwataer, FL on 11/11//2013. Voluntary: Firm Initiated...
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Company: GE Healthcare LLC Date of Enforcement Report: 12/18/2013 Class lI: PRODUCT GE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters...
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Company: Iba Dosimetry Gmbh Date of Enforcement Report:12/18/2013 Class lI: PRODUCT iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological Recall Number Z-0456-2014 REASON The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation....
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Company: Omnyx Llc Date of Enforcement Report:12/18/2013 Class lI: PRODUCT Digital Pathology System (DPS) Software version 1.1 The Omnyx” Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx” products are for...
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Company: Cincinnati Sub-Zero Products Inc Date of Enforcement Report:12/11/2013 Class lI: PRODUCT Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol...
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Company: Haemonetics Software Solutions Date of Enforcement Report:12/11/2013 Class lI: PRODUCT ElDorado Donor Doc Software, comprehensive donor health qualification computer system, run in a native Internet Explorer browser that is displayed in kiosk mode. Versions 2.5.0, 2.5.0 (SR1), 2.6.0, 2.6 (SR1), 2.7.0 Recall Number B-0008-14 REASON Blood Bank Software, with a defect or glitch, was...
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Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 12/11/2013 Class lI: PRODUCT Dimension Vista(R) 500 and Dimension Vista(R) 1500 – Reloaded Vista Vials – limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids. Recall Number Z-0430-2014 REASON There is the potential...
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Company: GE Healthcare It Date of Enforcement Report: 12/11/2013 Class lI: PRODUCT The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise...
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Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report: 12/11/2013 Class lI: PRODUCT syngo(R) Lab Data Manager – Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help...
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Company: Custom Ultrasonics, Inc. Date of Enforcement Report:12/4/2013 Class lI: PRODUCT Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. Recall Number Z-0426-2014 REASON Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution. RECALLING FIRM/MANUFACTURER Custom Ultrasonics, Inc.,...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:12/4/2013 Class lI: PRODUCT (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system Recall Number Z-0374-2014 REASON A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos...
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Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 12/4/2013 Class lI: PRODUCT ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System) The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger....
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:12/4/2013 Class lI: PRODUCT (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system Recall Number Z-0140-2014 REASON A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos...
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Company: GE Healthcare It Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially...
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Company: Spacelabs Healthcare, Llc Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment...
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Company: Carl Zeiss Meditec, Inc. Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians...
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Company: Siemens Healthcare Diagnostics Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.Recall Number Z-0343-2014, Z-0344-2014, Z-0345-2014, Z-0346-2014 REASON iemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to...
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Company:Philips Medical Systems North America Inc. Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis. Recall Number Z-0368-2014 REASON A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International...
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Company: Carl Zeiss Meditec, Inc. Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians...
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Company: GE Healthcare, LLC Date of Enforcement Report:11/27/2013 Class ll: PRODUCT GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating...
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Company: Hospira Inc Date of Enforcement Report: 11/25/2013 Class l: PRODUCT Hospira GemStar Infusion System Models 13000, 13100, 13150, 13086, 13087, 13088 The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous,...
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Company: GE Healthcare, LLC Date of Enforcement Report:11/20/2013 Class ll: PRODUCT AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems....
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Siemens syngo.plaza image processing system image processing radiological system Recall Number Z-0271-2014 REASON The firm became aware of an unintended behavior when using the syngo.plaza. The “Rename” functionality can cause an unintended patient merge if the patient is sent to another...
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Company: Hospira Inc Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT ) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with...
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Company:Philips Healthcare Informatics, Inc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare...
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Company: RAYSEARCH LABORATORIES AB. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0 Recall Number Z-0281-2014 REASON Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a...
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Company: Carestream Health Inc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and...
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Company:Nobel Biocare Usa Llc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery,...
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