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Company:Phadia US IncDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing,...
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Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT VITROS 5600 Integrated System, Catalog Number 6802413, IVD — Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents....
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This draft was replaced by a final guidance in August 2016. It is provided here for historical comparison only. FDA issued a draft “General Wellness: Policy for Low Risk Devices” guidance on January 20, 2015. This draft policy continues to redefine the borderline for FDA regulation/non-regulation of Health IT along with their MDDS and MMApps...
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The U.S. National Institute of Standards and Technology issued a document entitled “Framework for Improving Critical Infrastructure Cybersecurity” dated February 12, 2014.   This document is now being used by FDA as a reference in its cybersecurity program.  You can download version 1.0 here: Framework for Improving Critical Infrastructure Cybersecurity Version 1.0 See our later post...
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AAMI has filed a Project Initiation Notice with ANSI for a new standard on HIT risk management. The notice was published in the ANSI Standards Action publication on December 19. The notice is reproduced below. BSR/AAMI HIT1000-201x, Risk Management for Heath-IT (new standard) Stakeholders: The primary stakeholders are health IT producers and manufacturers, healthcare providers,...
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Micro Labs LimitedProduct: pharmaceutical manufacturing facility Date: 1/9/2015 1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)). a) During the inspection, your management admitted that employees in both of your Quality Control (QC) laboratories had frequently...
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Company:McKesson Israel Ltd..Date of Enforcement Report 1/8/2015 Class lI: PRODUCT McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices. Recall Number Z-0910-2015 REASON Software error discovered in the McKesson Cardiology ECG Management...
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/docs/scpred/AAMI-BITarticle_Ten_Questions_With_Alan_Kusinitz.pdf
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Company: Illumina Inc.Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries....
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Company: Illumina Inc.Date of Enforcement Report 12/31/2014 Class lII: PRODUCT Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform. Recall Number Z-0850-2015 REASON Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the...
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Company:Horiba Instruments Inc.Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC) results from an ABX...
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Company: on Beam Applications S.A.Date of Enforcement Report 12/31/2014 Class lI: PRODUCT adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device....
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Company: GE Healthcare It. Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have...
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Company: Bausch & Lomb Incorporated Rochester, NY Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY Recall Number Z-0862-2015 REASON A software anomaly was identified where the system may automatically transition from “Standby” to “Ready to Fire”...
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Company: Bausch & Lomb Incorporated Rochester, NY Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal...
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Company: Bausch & Lomb Incorporated Rochester, NY Date of Enforcement Report 12/31/2014 Class lI: PRODUCT Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal...
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Company: Carestream Health, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. Recall Number Z-0820-2015 REASON Reduced mammographic image quality when attempting to print true size multi-format images RECALLING FIRM/MANUFACTURER Carestream Health, Inc., Rochester, NY on...
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Company: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0. Recall Number Z-0821-2015 REASON Software Anomaly; Because of a software bug, the VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d)...
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Company: Philips Ultrasound, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging. Recall Number Z-0816-2015...
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Company: Philips Ultrasound, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products. Recall Number Z-0815-2015 REASON When using the...
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Company: Philips Ultrasound, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721. Diagnostic Ultrasound Imaging. Recall Number Z-0817-2015...
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Company: Philips Ultrasound, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. Recall Number Z-0818-2015 REASON When using the...
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The link provided is to a 2013 article entitled: “Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol.” Safety Assurance for EHR Article
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Novacyl Wuxi Pharmaceutical Co., Ltd. .Product: pharmaceutical manufacturing facility Date: 12/19/2014 1. Failure to manage laboratory systems with sufficient controls to ensure conformance to established specifications and prevent omission of data. Our inspection revealed serious deficiencies related to your documentation practices, including missing raw data. It is a basic responsibility of your quality unit to...
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Company: TomoTherapy Incorporated. Date of Enforcement Report 12/17/2014 Class lI: PRODUCT TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3) Recall Number Z-0507-2015 REASON Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw...
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Company: Mevion Medical Systems, Inc.. Date of Enforcement Report 12/17/2014 Class lI: PRODUCT MEVION S250, used for proton radiation therapy. Recall Number Z-0588-2015 REASON Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect...
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Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 12/17/2014 Class lI: PRODUCT Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Recall Number Z-0576-2015 REASON Printouts may be printed in incorrect...
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Company: INO Therapeutics (dba Ikaria). Date of Enforcement Report 12/17/2014 Class lI: PRODUCT INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units...
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Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 12/10/2014 Class lI: PRODUCT The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. Recall Number Z-0486-2015 REASON There is a potential issue on running Artis systems running software VC1x software...
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Customed Inc.Product: medical devices, including convenience packs for surgical procedures Date: 1/9/2015 Failure to validate the defined user needs and intended uses of the (b)(4) used as part of the quality system according to an established protocol, as required by 21 CFR 820.70(i). Specifically, your firm implemented (b)(4) to track product inventory (incoming materials, finished/released...
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/docs/FDAinfusionpumplifecycleguidance-ucm209337.pdf
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 Recall Number Z-0473-2015 REASON Software defect RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Cleveland, OH 11/9/2014. Voluntary:...
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Company: Abbott Molecular. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT Abbott m2000sp is intended use as an automated system for performing sample preparation for nucleic acid testing. Recall Number Z-0463-2015 REASON Abbott Molecular identified some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This may cause...
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Company:Vision Rt Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated. Recall Number Z-0464-2015 REASON Potential failure of AlignRT to assert interlock....
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Company: Toshiba American Medical Systems Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454 Recall Number Z-0450-2015 REASON Software issues RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Cleveland, OH 11/4/2014. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...
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Company: Elekta, Inc.. Date of Enforcement Report 11/26/2014 Class lI: PRODUCT MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number Z-0221-2015 REASON A problem can exist...
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Company: Accuray Incorporated Date of Enforcement Report 11/26/2014 Class lI: PRODUCT CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall Number Z-0218-2015...
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Seapine Software (seapine.com) which provides a variety of development tools published its 2014 report on the state of software development for medical devices. This report was generated based on input from 500 individuals in the medical device industry. It contains a breakdown of risk management methods used, key documentation challenges, requirements management approaches used, test...
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Company: Respironics California Inc. (a division of Philips Healthcare) Date of Enforcement Report 11/19/2014 Class I: Date Recall Initiated: September 17, 2014 PRODUCT Esprit V1000 and V200 Ventilators, Model V1000 and V200, Installed with 3rd Generation Power Supplies, and 3rd Generation Power Supply Repair Part Kits ? See complete listing of serial numbers. Manufactured and...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 11/19/2014 Class lI: PRODUCT Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures....
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Company: Integra LifeSciences Corp. Date of Enforcement Report 11/19/2014 Class lI: PRODUCT Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 Recall Number Z-0201-2015 REASON ntegra LifeSciences Corporation received 2 complaints that...
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Company:Maquet Cardiovascular Us Sales, Llc. Date of Enforcement Report 11/19/2014 Class lI: PRODUCT Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to...
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdf
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Company: Beckman Coulter Inc.. Date of Enforcement Report 11/12/2014 Class lI: PRODUCT Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 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...
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdf
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