Company:Boston Scientific CRM Corp Date of Enforcement Report 3/14/12 Class lll: PRODUCT LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. Recall # Z-1096-2012 REASON Patients are not able to perform setup. There...Read More

Company:Philips Medical Systems, Inc. Date of Enforcement Report 3/14/12 Class ll: PRODUCT TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #459800111661. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall # Z-1056-2012 REASON A number of non-conformances have been noted...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/14/12 Class ll: PRODUCT ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. The indication is to deliver X-ray, photon and electron radiation for the therapeutic treatment of cancer. Syngo RT Therapist v4.1, part number 8162815; Syngo RT Therapist Assist (off line system),...Read More

Company:Microsoft Amalga Date of Enforcement Report 3/14/12 Class ll: PRODUCT Microsoft Amalga – previously known as Microsoft Amalga Unified Intelligence System (UIS) 2009 Product Usage: Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continually updated data ecosystem to aggregate, store, display, and share disparate data either coming from many source systems or...Read More

Company:Philips Medical Systems, Inc. Date of Enforcement Report 3/14/12 Class ll: PRODUCT 1) Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/14/12 Class ll: PRODUCT Siemens syngo Imaging XS. Radiological image processing system. Model number 10496279. Recall # Z-1064-2012 REASON Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images/series from the Patient Browser using...Read More

Company:Philips Medical Systems Nederlands. Date of Enforcement Report 3/7/12 Class ll: PRODUCT Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a diagnostic device. Recall # Z-1125-2012 REASON There maybe incorrect values in the diffusion/perfusion maps. RECALLING FIRM/MANUFACTURER Philips Medical Systems Nederlands, Best, Netherlands, by...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/7/12 Class ll: PRODUCT Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system. Model number 10592457. Recall # Z-1127-2012 REASON There is a potential malfunction when using syngo.plaza VA20B_HF04 with USB dongle and archive license. In syngo.plaza VA20B_HF04, there is a scenario where...Read More

Company:Mindray DS USA, Inc. d.b.a. Mindray North America Date of Enforcement Report 3/7/12 Class ll: PRODUCT V Series Monitor. The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis...Read More

/docs/SCPRed/SoftwareCPR-Newsletter0312.pdfRead More

An article on the QMED website reporting on hacking of Medtronic Infusion pumps using remote wireless capability that could allow patient harm.Read More

The article “Build and Validate Safety in Medical Device Software”, available on the Medical Electronics Design Website at http://www.medicalelectronicsdesign.com or at the link provided above, provides an overview of the challenges and approaches to preventing and detecting software faults that can lead to hazardous situations. The article provides an overview of some of the relevant...Read More

Company:Philips Medical Systems Date of Enforcement Report 2/22/12 Class ll: PRODUCT ) Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken...Read More

Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/22/12 Class ll: PRODUCT Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and Ingenuity CT, Model Number: 728326). Intended to produce cross-sectional images of the body by comcomputer...Read More

Company:Leica Microsystems, Inc. Date of Enforcement Report 2/22/12 Class ll: PRODUCT Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201. The intended use of the microscope is for...Read More

Company:Spacelabs Healthcare, LLC Date of Enforcement Report 2/22/12 Class ll: PRODUCT Spacelabs Medical Ultraview SL Command Module, Model 91496. 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 of clinical environment other...Read More

Company:Vital Images, Inc. Date of Enforcement Report 2/22/12 Class ll: PRODUCT Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images...Read More

Company:Philips Medical Systems Date of Enforcement Report 2/15/12 Class ll: PRODUCT GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), a) Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), b) Model #882471. The device is a diagnostic imaging system for fixed or mobile installations that combines...Read More

Company:Volcano Corp. Date of Enforcement Report 2/15/12 Class ll: PRODUCT Volcano pcFM Software Kit. The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data. Model 6830 ComboMap Software...Read More

Company:Philips Medical Systems Date of Enforcement Report 2/15/12 Class ll: PRODUCT Pinnacle3 Radiation Therapy Planning System, software version 9.0. Model # Description 453560446041 Pinnacle3 version 9.0 English 453560446051 Pinnacle3 version 9.0 Simplified Chinese 453560446061 Pinnacle3 version 9.0 Traditional Chinese 453560446091 Pinnacle3 version 9.0 Dutch 453560446101 Pinnacle3 version 9.0 French 453560446111 Pinnacle3 version 9.0 German 453560446141...Read More

Recipient:Biochem Laboratories Inc. Product:TX1 Tissue Removal System Date: 2/17/2012 Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 CFR 211.68(b)]. For example: a. Your firm did not put in place requirements...Read More

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202511.htmRead More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report 2/8/12 Class ll: PRODUCT STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report 2/1/12 Class ll: PRODUCT Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457. Recall # Z-0827-2012 REASON The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report 2/1/12 Class ll: PRODUCT Syngo Imaging XS, all versions Radiological image processing system. Model number 10496279. Recall # Z-0514-2012 REASON The “Rename” functionality can cause an unintended patient merge if the renamed patient is sent to another system. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Solutions USA, Inc.,...Read More

The European Commission has issued a final guidance on standalone software entitled: “GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES.”  Updated in 2015.Read More

The Institute of Medicine report is at the link provided. Health IT and Patient Safety ReportRead More

For devices where the medical device manufacturer intends to maintain remote access capability for service and updates, controls are needed to ensure this access does not compromise the security or operation of the device. There is one FDA recognized standard that addresses this for clinical laboratory devices, but many of the provisions could be instructive...Read More

The Joint Initiative on SDO Global Health Informatics Standardization is formed to enable common, timely health informatics standards by addressing and resolving issues of gaps, overlaps, and counterproductive standardization efforts.Read More

Company:CareFusion 209 Inc Date of Enforcement Report 1/25/12 Class ll: PRODUCT NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue software is intended to aid the hospital in tracking patient data from collection to review...Read More

Company:RaySearch Laboratories AB Date of Enforcement Report 1/25/12 Class ll: PRODUCT RayStation Version 2.0.0.15 Consult instruction for use. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to...Read More

The UL 1998 revision comment period ends March 5, 2012. The suggested revisions include: Reducing ambiguity in the applicability of the requirements for Negative Condition Branch failure mode and stress testing Revision of requirements to address the effects of power supply voltage variations Revised formating of Table A2.1 to clarify acceptable measures for each requirement...Read More

Recipient: CuraeLase, IncProduct:CL 1000 IR Laser System Date: 12/9/2011 Quality System Regulation Concerns We also note the following concerns regarding Quality System (QS) regulation requirements (21 CFR Part 820): 6. Failure of the DMR for each device type to include or refer to the location of the device specifications, including software specifications, as required by...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 1/11/12 Class ll: PRODUCT GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular;...Read More

Company:AGFA Corp Date of Enforcement Report 1/11/12 Class ll: PRODUCT IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2. Recall # Z-0211-2012 REASON Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable. RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corp., Greenville, SC, by letter dated May...Read More

Company:SCC Soft Computer Date of Enforcement Report 1/11/12 Class ll: PRODUCT SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. Product Usage: SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing...Read More

Company:Philips Medical Systems Ibc. Date of Enforcement Report 1/11/12 Class ll: PRODUCT 1) Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243. The recalled device systems are equipped with Version 3.5 Beta 1 software. Recall # Z-0334-2012; 2) Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231. The recalled device...Read More

Company:SCC Soft Computer Date of Enforcement Report 1/11/12 Class ll: PRODUCT SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of...Read More

Company:Philips Medical Systems Date of Enforcement Report 1/11/12 Class ll: PRODUCT Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data. Model Number 882488: EBW NM Special Model...Read More

Company:SCC Soft Computer. Date of Enforcement Report 1/4/12 Class ll: PRODUCT SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. SoftMic is a laboratory information system to be used in medical research, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing,...Read More

Company:Roche Diagnostics Operations, Inc. Date of Enforcement Report 1/4/12 Class ll: PRODUCT cobas c 311 Analyzer, Part Number: 04826876001 In-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. Recall # Z-0310-2012...Read More

/docs/SoftwareCPRNewsbefore2012not-also-in-Library.pdfRead More

Company:Boston Scientific CRM Corp. Date of Enforcement Report 12/27/11 Class ll: PRODUCT LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Application is loaded onto the Model 3120 programmers. These programmers are used during in-office...Read More

Company:Philips Medical Systems (Cleveland) Inc. Date of Enforcement Report 12/27/11 Class ll: PRODUCT 1) Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine...Read More

Company:CareFusion. Date of Enforcement Report 12/8/11 Class l: Date Recall Initiated: September 8, 2011 PRODUCT AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly...Read More

Company:AGFA Corp. Date of Enforcement Report 12/21/11 Class ll: PRODUCT IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting. Recall # Z-0212-2012 REASON Incorrect entries in mapping files could lead to inaccurate measurement display...Read More

Company:Philips Healthcare Inc. Date of Enforcement Report 12/21/11 Class ll: PRODUCT Philips Multi Diagnost Eleva with Flat Software R5.2.2. Philips MultiDiagnost Eleva system is intended to be Intended used as a multifunctional/Universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive...Read More

Company:AGFA Corp. Date of Enforcement Report 12/21/11 Class ll: PRODUCT IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. Recall # Z-0272-2012 REASON Potential for misattribution of data and for a report to become unavailable when the user requests...Read More

Company:Steris Corp Date of Enforcement Report 12/15/11 Class ll: PRODUCT SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3. Recall #Z-0278-2012. REASON Potential for patient data to be sent to the wrong patient record. A software...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 12/15/11 Class ll: PRODUCT 1) Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical...Read More