A committee draft (CD) of “IEC TR 62366-2: Medical devices – Part 2: Guidance on the application of usability engineering to medical devices” was issued for comment. This technical report provides medical device manufacturers with guidance on how to integrate usability engineering (also called human factors engineering) principles and user interface design practices into their...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 1/28/2015 Class lI: PRODUCT VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 – in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 – in vitro quantitative, semi-quantitative, and qualitative...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 1/28/2015 Class lI: PRODUCT Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull,...Read More

Company:Maquet Medical Systems USADate of Enforcement Report: 1/28/2015 Class lI: PRODUCT TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the cental operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction...Read More

FDA added the following standards to their recognized standards list and published the new recognitions January 2015. IEC TR 80001-2-5 2014. Application of risk management for IT networks incorporating medical devices–Part 2-5: Application guidance–Guidance on distributed alarm systems. IEEE Std 11073-10425- Health informatics 2014. Personal health device comunication, Part 10425: Device Specialization–Continuous Glucose Monitor (CGM)....Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, 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 Immunodiagnostic Products Reagents. Recall Number Z-0967-2015 REASON Software Anomaly: the firm has identified...Read More

Company:Brainlab AGDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT Plan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. Recall Number Z-0956-2015 REASON iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD — Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products...Read More

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,...Read More

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....Read More

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...Read More

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...Read More

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,...Read More

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...Read More

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...Read More

/docs/scpred/AAMI-BITarticle_Ten_Questions_With_Alan_Kusinitz.pdfRead More

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...Read More

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....Read More

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...Read More

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”...Read More

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...Read More

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...Read More

/docs/FDARadiationBiodosimetryDevicesDraft.pdfRead More

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....Read More

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...Read More

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...Read More

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)...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

/docs/FDADraft510kTransferGuidance122214.pdfRead More

/docs/FDADraft510kTransferGuidance122214.pdfRead More

The link provided is to a 2013 article entitled: “Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol.” Safety Assurance for EHR ArticleRead More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

/docs/FDAinfusionpumplifecycleguidance-ucm209337.pdfRead More

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:...Read More

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...Read More

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....Read More

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...Read More

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...Read More

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...Read More

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...Read More