Company:Zyno Medical LLC .Date of Enforcement Report 4/10/2013 Class ll: PRODUCT Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient. Recall Number Z-1024-2013 REASON Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the...Read More

Company:Horiba Instruments, Inc dba Horiba Medical Date of Enforcement Report 4/10/2013 Class ll: PRODUCT ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received...Read More

Company:Animas Corporation Date of Enforcement Report 4/10/2013 Class l: PRODUCT Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. Recall Number Z-0993-2013 REASON Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component...Read More

Company:Philips Medical Systems .Date of Enforcement Report 4/10/2013 Class ll: PRODUCT Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall Number Z-1029-2013 REASON Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/10/2013 Class lll: PRODUCT Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids. Recall Number Z-1046-2013 REASON Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System...Read More

IEC/TR 62348 is a technical report that assesses “the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition.”  The report is intended to be a tool for manufacturers to understand the impact of Amendment 1:2012 changes to 60601-1 from the...Read More

Company:Biomerieux Inc .Date of Enforcement Report 4/3/2013 Class ll: PRODUCT VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700...Read More

Company:Toshiba American Medical Systems Inc .Date of Enforcement Report4/3/2013 Class ll: PRODUCT Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures. Recall Number Z-0994-2013 REASON Lost and incorrect images. When using the “F-Rec” fluoroscopy image acquisition recording option in the “manual mode” an infrequent software error may...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/3/2013 Class ll: PRODUCT Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system. Recall Number Z-0997-2013 REASON The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under...Read More

CompanyVital Images, Inc. .Date of Enforcement Report 4/3/2013 Class ll: PRODUCT Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/20/2013 Class ll: PRODUCT Siemens Somatom CT’s equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system. Recall Number Z-0948-2013 REASON Sporadic hang-up malfunctions concerning 3D reconstructions during activated “Preview Image” functionality RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 3/20/2013 Class ll: PRODUCT Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner. Z-0935-2013 REASON An error on the SR Viewer Reporting Tool...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/20/2013 Class ll: PRODUCT Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems 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 at different angles and planes. This...Read More

How Health IT will be regulated was being discussed by the U.S. government in February. A Health IT Patient Safety Action & Surveillance Plan was circulated by the Office of the National Coordinator for HIT (ONC) in December and is at the link provided. https://www.healthit.gov/sites/default/files/safetyplanhhspubliccomment.pdf A report on An Oversight Framework for Assuring Patient Safety in...Read More

Puget Sound Blood Center and ProgramProduct: blood and blood products Date: 3/16/2013 During the inspection, FDA investigators documented significant deviations from applicable current Good Manufacturing Practice (cGMP) regulations for blood and blood products, Title 21, Code of Federal Regulations (21 CFR), Parts 606, 610 and 640 and the cGMP regulations for finished pharmaceuticals, 21 CFR...Read More

Company:Steris Corporation Date of Enforcement Report 3/13/2013 Class ll: PRODUCT AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities. Recall Number Z-0915-2013 REASON The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/13/2013 Class ll: PRODUCT Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/13/2013 Class ll: PRODUCT SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY. Recall Number Z-0907-2013 REASON Siemens...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 3/13/2013 Class ll: PRODUCT GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with...Read More

Company:Beckman Coulter Inc. Date of Enforcement Report 3/13/2013 Class ll: PRODUCT Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium. Recall Number Z-0913-2013 REASON Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration...Read More

Company:Philips Healthcare Inc Date of Enforcement Report 3/13/2013 Class ll: PRODUCT Philips Digital Diagnost Stationary radiographic system. Recall Number Z-0900-2013 REASON When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 3/6/2013 Class ll: PRODUCT GE Healthcare Definium 5000 / 5220493 X-Ray System This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts. Recall Number Z-0703-2013 and Z-0704-2013 REASON It was discovered GE Healthcare...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall Number...Read More

Company:Intel-GE Care Innovations LLC. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents’ movements. Recall Number Z-0877-2013 REASON Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 3/6/2013 Class ll: PRODUCT GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System Recall Number Z-0761-2013 REASON GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Ingenuity TF PET/CT Diagnostic imaging system Recall Number Z-0897-2013 REASON Issues have been detected in the Ingenuity TF PET/CT currently running Ingenuity TF PET/CT system software version 4.0.0.26635 that if they were to re-occur, could cause a risk for patients. RECALLING FIRM/MANUFACTURER Philips...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System. Recall Number Z-0881-2013 REASON Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244. Recall Number Z-0880-2013 REASON Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips Medical Systems, GEMINI LXL – Model #882412; GEMINI TF 16 – Model #882470 and Model #882473; GEMINI TF 64 – Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that...Read More

Company:Philips Healthcare Inc. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system Recall Number Z-0884-2013 REASON When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset...Read More

Company:Varian Medical Systems, Inc. Oncology Systems Date of Enforcement Report 2/27/2013 Class ll: PRODUCT Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. Recall Number Z-0867-2013 REASON Varian has identified an anomaly with the Eclipse...Read More

Company:Elekta, Inc. Date of Enforcement Report 2/27/2013 Class ll: PRODUCT Monaco RTP System. Radiation treatment planning. Recall Number Z-0841-2013 REASON The beam is displayed at the “gantry” angle, but the dose is calculated at the “rotation_start” angle. RECALLING FIRM/MANUFACTURER Elekta, Inc., Atlanta, GA,I on 2/11/2013. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

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Company:Mindray DS USA, Inc. d.b.a. Mindray North America Date of Enforcement Report 2/20/2013 Class ll: PRODUCT Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and...Read More

Company:Terumo Cardiovascular Systems Corporation Date of Enforcement Report 2/20/2013 Class ll: PRODUCT Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels. Recall Number Z-0802-2013 REASON Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 2/20/2013 Class ll: PRODUCT GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories. Recall Number Z-0813-2013 REASON GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on...Read More

Company:Blood Bank Computer Systems, Inc Date of Enforcement Report 2/13/2013 Class ll: PRODUCT Blood Bank Control System (BBCS) Primary Application 5.0 – software for device. Recall Number B-0726-13 REASON Blood Bank software, with a defect or glitch, was distributed.. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc Auburn, WA on 10/18/2011. Voluntary: Firm Initiated recall is...Read More

Company:Dept Of Veterans Affairs Office Of Information & Technology Date of Enforcement Report 2/13/2013 Class ll: PRODUCT VistA Blood Establishment Computer Software (VBECS) Recall Number B-0673-13 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Dept Of Veterans Affairs Office Of Information & Technology, Hines, IL on 11/2/2012. Voluntary: Firm Initiated recall is...Read More

Company:GE Healthcare, LLC. Date of Enforcement Report 2/6/2013 Class ll: PRODUCT AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6. Recall Number Z-0754-2013 REASON It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image...Read More

Company:Roche Molecular Systems, Inc. Date of Enforcement Report 2/6/2013 Class ll: PRODUCT COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. Recall Number Z-0762-2013 REASON The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test...Read More

Company:Hamilton Medical Inc. Date of Enforcement Report 2/6/2013 Class l: PRODUCT HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. Recall Number Z-0741-2013 REASON Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high...Read More

Company:Envoy Medical Corp Date of Enforcement Report 2/6/2013 Class ll: PRODUCT Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX. Part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer. Recall Number Z-0750-2013 REASON Envoy Medical is conducting a voluntary correction...Read More

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Company:Roche Diagnostics Operations, Inc. . Date of Enforcement Report 1/30/2013 Class ll: PRODUCT Roche COBAS INTEGRA 400 and 400 plus Analyzer The Roche COBAS INTEGRA 400/400 plus Analyzer is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. Recall Number Z-0696-2013 REASON A software...Read More

Company:Becton Dickinson & Co. Date of Enforcement Report 1/30/2013 Class ll: PRODUCT BD MAX ™ (6 channel) Instruments, Catalog number 441916, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA*** The BD MAX” System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification...Read More

A workshop with approximately 80 invited medical wireless experts was held in October 2012. This report, at the link provided, documents the discussion and outcomes of this workshop. A follow-up meeting is planned for March 2013. 2012_Wireless_Workshop_PublicationRead More

The total number of FDA software, computer system, and electronic records warning letters in 2012 is approximately 30 which is up from 18 in 2011 and fewer in 2009 and 2010. This is based on the keyword searches we perform on a regular basis but is not guaranteed to be comprehensive.Read More

Company: Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 1/23/2013 Class ll: PRODUCT Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer...Read More

Company: Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 1/23/2013 Class ll: PRODUCT Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 – Model #728231; and Ingenuity CT – Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended...Read More

Company: Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 1/23/2013 Class ll: PRODUCT Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an...Read More