Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT enGen (TM) Laboratory Automation Systems (enGen) with TCAutomation (TM) — For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. — Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT enGen (TM) Laboratory Automation System Configured with TCAutomation” Software v3.5 — For in vitro quantitative measurement of a variety of analytes of clinical interest — The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use. Recall Number Z-1736-2014 REASON Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS...Read More

Company: Mckesson Medical Immaging.Date of Enforcement Report:6/18/2014 Class lI: PRODUCT Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. Recall Number Z-1728-2014 REASON...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use. Recall Number Z-1735-2014 REASON Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/18/2014 Class lI: PRODUCT IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352 Recall Number Z-1746-2014 REASON IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/18/2014 Class lI: PRODUCT Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor. Recall Number Z-1783-2014 REASON If a customer creates customized trend scales in the trend review tile and the iX or...Read More

See the ONC 10-year roadmap to achieving a “learning health system” based on an interoperable health IT ecosystem at the link provided. ONC 10 year Interoperability Concept PaperRead More

A number of draft standards were released for comment, including including several related to specific security for medical devices and Health IT: AAMI TIR38 – AAMI Medical device safety assurance case guidance IEC Health SW Standards Framework ISO 27799 Health informatics “Information management in health using ISO/IEC 27002” IEC TR 80001-2-8, Application of risk management...Read More

Company: Spacelabs Healthcare Inc Date of Enforcement Report:6/11/2014 Class lI: PRODUCT Spacelabs Medical Ultraview SL” Command Module, Model 91496. Detector and alarm, arrhythmia. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type...Read More

Company: BRainlab AG.Date of Enforcement Report:6/11/2014 Class lI: PRODUCT Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/11/2014 Class lI: PRODUCT enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 — For in vitro quantitative measurement of a variety of analytes of clinical interest — Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition...Read More

Company: Toshiba American Medical Systems IncDate of Enforcement Report:6/11/2014 Class lI: PRODUCT Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting. Recall Number Z-1714-2014 REASON Toshiba America Medical Systems, Inc. initiated a recall of Toshiba Infinix X-Ray (INFX-8000V/UU), because it has been...Read More

Company: BRainlab AG.Date of Enforcement Report:6/11/2014 Class lI: PRODUCT ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery. Recall Number Z-1707-2014 REASON When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended...Read More

Company: Philips Medical Systems (Cleveland) IncDate of Enforcement Report:6/11/2014 Class lI: PRODUCT IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing. Recall Number Z-1678-2014 REASON During SPECT reconstructions using Attenuation Correction and Scatter...Read More

Company: Physio-Control, Inc.Date of Enforcement Report:6/42014 Class lI: PRODUCT LIFEPAK 1000 defibrillator. The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest. Recall Number Z-1660-2014 REASON Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to...Read More

Company: NAGFA Corp.Date of Enforcement Report:6/4/2014 Class lI: PRODUCT IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography. Recall Number Z-1662-2014 REASON Failure to effectively install and test a hotfix to correct the...Read More

Company: GE Healthcare Date of Enforcement Report:6/4/2014 Class lI: PRODUCT The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 6/4/2014 Class lI: PRODUCT ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. Recall Number Z-1667-2014 REASON Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) – may incorrectly display the color flow data in the wrong position and when...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 6/42014 Class lI: PRODUCT ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. Recall Number Z-1668-2014 REASON Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could...Read More

Just a reminder that FDA maintains a blog at the link provided. This generally contains short announcements with some explanation from FDA leads on policy and specific projects across all FDA divisions although one select specific divisions using the categories options. One recent posting was from Bakul Patel of the device center regarding the recent...Read More

http://open.fda.govRead More

In SoftwareCPR’s experience, translations and localization of user interfaces and labeling of medical devices for distribution in a variety of geographic regions can be challenging and can present safety issues if not properly handled.  Alan Kusinitz of SoftwareCPR® co-authored an article on localization risk management with one of the large companies that provides such services...Read More

http://tinyurl.com/k29hoseRead More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/28/2014 Class lI: PRODUCT 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer. Recall Number Z-1645-2014 REASON Table may lose calibration during patient treatment, which may cause the possibility of mistreatment. RECALLING FIRM/MANUFACTURER Siemens Medical...Read More

Company: GE Healthcare Date of Enforcement Report:5/28/2014 Class lI: PRODUCT GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location. The device is indicated for use by qualified medical personnel only. Recall Number Z-1640-2014 REASON When...Read More

Company: Philips Healthcare Informatics, Inc.Date of Enforcement Report 5/28/2014 Class lI: PRODUCT Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/28/2014 Class lI: PRODUCT syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also...Read More

It appears that the Center directed ORA to inspect Class I firms and provided each regional/district offices with a list of 50 firms to choose from. These inspectionsappear to be in part a validation exercise of the risk based approach to only inspecting higher risk firms. We are assuming it is for the remainder of...Read More

STERIS Corporation Product:facility sterilizes medical devices Date:5/22/2014 1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100. Your CAPA procedure, PROC-00007, Revision 19, is deficient in that it does not adequately describe how to identify, correct and prevent the recurrence of nonconforming product and other...Read More

Company: Baxter Corporation EnglewoodDate of Enforcement Report:4/2/2014 Class I: PRODUCT Baxter Corporation Englewood, ABACUS Total Parenteral Nutrition Calculation Software, Versions 3.1, 3.0, 2.1, and 2.0 – Software Errors May Cause Toxic or Overdose Symptoms. ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition),...Read More

Company: Mckesson Medical ImagingDate of Enforcement Report:5/21/2014 Class lI: PRODUCT McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. Recall Number Z-1617-2014 REASON High priority alert...Read More

Company: SCC Soft Computer Date of Enforcement Report:5/21/2014 Class lI: PRODUCT SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory...Read More

Company: CareFusion 303, Inc.Date of Enforcement Report:4/23/2014 Class I: PRODUCT Alaris Pump Module (Model 8100), Software Version 9.1.18 The Alaris Pump Model 8100 is a large volume infusion pump. It is intended for use in health care facilities that use infusion for the delivery of fluids, medicines, blood, and blood products using continuous or periodic...Read More

Company: Codman & Shurtleff, Inc Date of Enforcement Report:5/21/2014 Class lI: PRODUCT MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Recall Number Z-1571-2014 REASON A...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/21/2014 Class lI: PRODUCT Syngo Dynamics Product Usage: Syngo Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for...Read More

Company: Nellcor Puritan Bennett Inc. (dba Covidien LP)Date of Enforcement Report:5/21/2014 Class lI: PRODUCT Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. Recall...Read More

http://www.fda.gov/downloads/Training/CDRHLearn/UCM311629.pdfRead More

http://tinyurl.com/ok6scdbRead More

Company: Shimadzu Medical Systems Date of Enforcement Report:5/14/2014 Class lI: PRODUCT Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices. Recall Number Z-1569-2014 REASON Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a...Read More

Company: INO Therapeutics Date of Enforcement Report:5/14/2014 Class lI: PRODUCT INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting...Read More

Company: GE Healthcare Date of Enforcement Report:5/14/2014 Class lI: PRODUCT Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with...Read More

Company: GE Healthcare LLC Date of Enforcement Report:5/7/2014 Class lI: PRODUCT GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #’s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting...Read More

Sun Pharmaceutical Industries Limited Product: pharmaceutical manufacturing facility Date:5/7/2014 1. Failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards. our firm frequently performs ?unofficial testing? of samples, disregards the results, and reports results from additional tests. For example, during stability testing, your...Read More

Company: Hospira Inc..Date of Enforcement Report:5/7/2014 Class I: PRODUCT GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX Recall Number Z-1512-2014 REASON There...Read More

Company: Brainlab AG Date of Enforcement Report 5/7/2014 Class lI: PRODUCT ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X...Read More

ECRI Institute published its Top 10 Patient Safety Concerns for Healthcare Organizations to give healthcare organizations a gauge to check their track record in patient safety. The list originally appeared in its Healthcare Risk Control (HRC) System newsletter, the Risk Management Reporter, and is reprinted in this report. The list is partly based on more...Read More

This white paper provides an update of the proposed revisions to EU medical device regulation as of April 2014. BSI WP EU RegulationsRead More

The following draft standards are being circulated for comment or ballot. More information is availale to Standards Navigator Subscribers in the the Standards Navigator topic:-IEC 62304 Amendment CDV -$ISO 16142-1 DIS -ISO 90003 FDIS -ISO 15289 FDIS -ISO 24748-4 DIS -ISO 24748-6 NPRead More

This white paper provides an update of the proposed revisions to EU medical device regulation as of April 2014. Green Paper on Mobile HealthRead More