Company: Hitachi Medical Systems America Inc Date of Enforcement Report: 6/26/2013 ClassL ll: PRODUCT Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the...Read More

Company: GE Healthcare.Date of Enforcement Report: 6/26/2013 ClassL ll: PRODUCT GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced  vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5...Read More

Company: Tecan US, Inc.Date of Enforcement Report: 6/26/2013 ClassL ll: PRODUCT Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational...Read More

Company:Respironics, Inc Date of Enforcement Report6/20/13 Date Recall Initiated: 6/2/2013 Class l: PRODUCT Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631)...Read More

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Company: American Optisurgical.Date of Enforcement Report: 6/12/2013 ClassL Ill: PRODUCT Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging. Recall Number Z-1441-2013 REASON Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different...Read More

Company:Symbios Medical Products.Date of Enforcement Report 6/12/2013 Class I: PRODUCT Part 510031 Disposable Single Infusion Pump, quantity Includes… TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO… found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 – BP, w/ Epidural...Read More

Company: American Optisurgical. Date of Enforcement Report: 6/12/2013 Class ll: PRODUCT American Optisurgical’s TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. Recall Number Z-1516-2013 REASON The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board....Read More

Company: Canon Inc.Date of Enforcement Report: 6/5/2013 Class ll: PRODUCT Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. Recall Number Z-1404-2013 REASON Canon Inc. had received 17 claims from our foreign...Read More

Company: Alpine Biomed Aps.Date of Enforcement Report: 6/5/2013 Class ll: PRODUCT Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV, 9033A0044, 9033A0073AA, 9031A0063, 9033A0523, 9033A071143, 9033A072143, 9031A006406, 9031A006506, 9031A070106, 9033A004606 9033A004706, 9033A007406, 9033A0537, 9033A0544, 9033A071106, 9033A072106, 9033A0524,...Read More

Company: Beckman Coulter Inc.Date of Enforcement Report: 6/5/2013 Class ll: PRODUCT Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration...Read More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 6/5/2013 Class ll: PRODUCT RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number Z-1419-2013 REASON Under some circumstances, imported CT, MR and...Read More

Company: Intel-GE Care Innovations LLC .Date of Enforcement Report: 5/29/2013 Class ll: PRODUCT QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. Recall Number Z-1374-2013 and Z-1375-2013 REASON ers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. RECALLING FIRM/MANUFACTURER Intel-GE...Read More

Company: Medical Information Technology, Inc.Date of Enforcement Report: 5/29/2013 Class ll: PRODUCT MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH’s Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information. Recall Number Z-1365-2013 REASON Incorrect transmission of laboratory results. RECALLING FIRM/MANUFACTURER Medical Information Technology, Inc., Westwood,...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 5/29/2013 Class ll: PRODUCT Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips...Read More

Company: Linvatec Corp. dba ConMed Linvatec Date of Enforcement Report: 5/29/2013 Class ll: PRODUCT Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures. Recall Number Z-1340-2013 REASON The VP1600 HD Still Capture Image System is recalled due to an anomaly...Read More

RPG Life Sciences LimitedProduct: pharmaceuticals. Date: 5/28/2013 Our investigator observed specific violations during the inspection, including, but not limited to, the following: 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)). Additionally, during an audit of the...Read More

FDA issued a compliance letter to a company distributing an uncleared Mobile App for reading urine analysis strips on May 21, 2013. The full text of this letter is on our warning letter page.Read More

Puget FDA Mobile App Compliance LetterProduct:Letter to Biosense Technologies Private Limited concerning the uChek Urine Analyzer Date: 5/21/2013 It has come to our attention that you are currently marketing the uChek Urine analyzer, which is intended for use with Siemens Multistix SG10, Siemens Multistix SG, Siemens Uristix, Bayer Diastix, and Bayer Keto-Diastix reagent strips for...Read More

Company: Olympus America Inc. Date of Enforcement Report: 5/15/2013 Class ll: PRODUCT Olympus SurgMaster UES-40 electrosurgical unit (“UES-40”) Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed...Read More

Company: GE Healthcare.Date of Enforcement Report: 5/8/2013 Class ll: PRODUCT GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device. Recall Number Z-1207-2013 REASON GE Healthcare has recently become aware of a Reformat Image Flip Issue associated...Read More

Company: GE Healthcare LLCDate of Enforcement Report: 5/8/2013 Class ll: PRODUCT GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device. Recall Number Z-1208-2013 REASON GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from...Read More

Company:Siemens MedicalDate of Enforcement Report 5/8/2013 Class ll: PRODUCT Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of...Read More

Company:GE HealthcareDate of Enforcement Report 5/1/2013 Class ll: PRODUCT GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration...Read More

Company: Stellate SystemsDate of Enforcement Report: 5/1/2013 Class ll: PRODUCT Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 5/1/2013 Class ll: PRODUCT AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications...Read More

This document provides answers to questions that have been asked to notified bodies regarding using EN 62304 for regulatory purposes in the EU. FAQ 62304Read More

The debate over ISO 14971 continues between industry and the European Commission. The joint ISO & IEC working group responsible for ISO 14971 met and determined that ISO 14971 still represents the state of the art for medical device risk management and that no changes were needed, despite the position of the EC that ISO...Read More

Company: Horiba Instruments, Inc dba Horiba Medical .Date of Enforcement Report: 4/24/2013 Class ll: PRODUCT HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes. Recall Number Z-1141-2013 REASON HORIBA Medical is informing all ABX PENTRA 400 Analyzer with...Read More

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Company:Carefusion Corp..Date of Enforcement Report 4/24/2013 Class I: PRODUCT Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Recall Number Z-1098-2013 REASON The recall was initiated because Carefusion has received reports of a communication error on...Read More

Company:Carefusion Corp..Date of Enforcement Report 4/24/2013 Class Il: PRODUCT Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Recall Number Z-1112-2013 REASON The recall was initiated because Carefusion has identified potential risk associated with bolus programming...Read More

Company: Maquet Cardiovascular, LLC.Date of Enforcement Report: 4/24/2013 Class ll: PRODUCT MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/24/2013 Class ll: PRODUCT Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple interfaces for patient registration,...Read More

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Company:GE HealthcareDate of Enforcement Report 4/24/2013 Class ll: PRODUCT GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 4/24/2013 Class ll: PRODUCT Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple...Read More

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Brian Pate of SoftwareCPR now leads our specialized validation services for Mobile Medical Apps (MMApps), including our own simulator-based testing and automated unit and functional testing. For mobile apps that are regulated medical devices, we provide full design control and premarket submission support by compliance and validation experts with specific mobile app technical knowledge that...Read More

IEC SC 62A has agreed that the 2nd edition of 62304 will be expanded to cover all Health Software, not just medical devices. In the interim, an amendment will be issued to clarify current safety classification as well as application of 62304 for legacy software (this was originally intended to be done as part of...Read More

Company:AGFA Corp. .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT IMPAX CV 7.8 SU3 – OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. Recall Number Z-1069-2013 REASON Software design...Read More

Company:Blood Bank Computer Systems, Inc .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning. Recall Number Z-1068-2013 REASON It has been found that due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a...Read More

Company:AGFA Corp. .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. Recall Number Z-1070-2013 REASON Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the...Read More

Company:Blood Bank Computer Systems, Inc .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation. Recall Number Z-1096-2013 REASON GE...Read More

Company:Blood Bank Computer Systems, Inc .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT Blood bank software Primary Application with Model numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1 Recall Number B-1345-13 REASON Blood Bank Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc, Auburn, WA, on 12/5/2012. Voluntary: Firm Initiated recall...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