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Company: Boston Scientific CRM Corp Date of Enforcement Report 6/15/2011 Class ll: PRODUCT Boston Scientific’s LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server software, Model 6465 for European Union LATITUDE 6.2 Patient Management System Website Server software, Model 6441 for Canada Server software, Model 6442...
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Company: Toshiba American Medical Systems Inc. Date of Enforcement Report 6/15/2011 Class ll: PRODUCT 1) Toshiba Infinix-i, INFX-8000C. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1871-2011; 2) Toshiba Infinix-i, INFX-8000F. The expected usage of these devices is for fluoroscopy studies for various...
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Company: Computerized Medical Systems Inc. Date of Enforcement Report 6/8/2011 Class ll: PRODUCT XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2408-2011 REASON XiO Software is not transferring the correct information...
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Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 6/8/2011 Class ll: PRODUCT ACUSON S2000 ultrasound system. Intended for the following applications: Fetal, abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular Applications. Model Number 10041461-ACUSON S2000. Recall # Z-2051-2011 REASON The Firm discovered a software...
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Company:Cepheid. Date of Enforcement Report 6/8/2011 Class ll: PRODUCT Xpert Infinity Software, V 4.1a. System software for GeneXpert Infinity 48. Recall # Z-2401-2011 REASON A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are...
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Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 6/1/2011 Class ll: PRODUCT LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Electronic patient records management system. Model Product Number LANTIS COMMANDER 4503178 LANTIS System 5835991 LANTIS Commander 6.1 5493072 LANTIS...
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Company:ZOLL Medical Corp. Date of Enforcement Report 6/1/2011 Class ll: PRODUCT Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11. The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may...
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Company:Bio-Rad Laboratories Date of Enforcement Report 6/1/2011 Class ll: PRODUCT Software CD is labeled in part: “BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***” The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data...
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Company:Philips Medical Systems (Cleveland) Inc. Date of Enforcement Report 6/1/2011 Class ll: PRODUCT 1) Brilliance iCT, Computed Tomography X-Ray System, including the Brilliance iCT SP system, Model Numbers: 728311 and 728306. The affected systems are equipped with the following software version: 3.2.0.19010. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray...
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Company:Digisonics, Inc.Date of Enforcement Report 5/25/2011 Class ll: PRODUCT DigiView software release 3.4.4.4 through 3.5.5.2. Digiview is a digital image management and reporting system with an associated clinical database. It provides capture, review and storage of images together with report creation and data basing. Recall # Z-2166-2011 REASON Failure of software to update some measurements...
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Company:Respironics Novametrix, LLC., .Date of Enforcement Report 5/25/2011 Class ll: PRODUCT 1) Philips NM3 Monitors, Model 7900 PHILIPS NM3 Monitor, English – P/N 1051674 PHILIPS NM3 Monitor, English Refurbished – P/N U1051674 PHILIPS NM3 Monitor, English, Demo Unit – P/N DU1051674 PHILIPS NM3 Monitor, Spanish – P/N 1060462 NM3 is a multi-parameter patient monitor that...
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Company:Varian Medical Systems, Inc.Date of Enforcement Report 5/18/2011 Class ll: PRODUCT The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup...
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Company:Philips Healthcare Inc.Date of Enforcement Report 5/18/2011 Class ll: PRODUCT Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link. Recall # Z-2175-2011 REASON Edits to an order can result in unintended scheduled interventions...
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Company:Quest Medical, Inc.Date of Enforcement Report 5/18/2011 Class lll: PRODUCT Quest MPS and MPS 2 Consoles, Quest Medical, Inc., an Atrion Company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS...
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Company:Beckman Coulter Inc.Date of Enforcement Report 5/18/2011 Class ll: PRODUCT 1) UniCel DxI 800 Access Immunoassay Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanufactured A25288, DxI 800 with spot B A71456, DxI 800 Reconditioned A25285 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of...
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Company:Bio-Rad Laboratories Inc.Date of Enforcement Report 5/18/2011 Class lll: PRODUCT Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative...
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Company:Bio-Rad, Laboratories IncDate of Enforcement Report 5/18/2011 Class ll: PRODUCT Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. a) Catalog Numbers: 270-2415 and b) 270-2417; The Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in...
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/docs/QSR21CFR820BasicIntroductionKTrautman0511.pdf
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Company: Hospira Inc. Date of Enforcement Report 5/11/2011 Class l: PRODUCT LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Electronic patient records management system. Model Product Number LANTIS COMMANDER 4503178 LANTIS System 5835991 LANTIS Commander 6.1 5493072 LANTIS 6.1 Complete...
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Company:Bio-Rad, Laboratories IncDate of Enforcement Report 5/11/2011 Class ll: PRODUCT VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper...
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Company: Beckman Coulter Inc. Date of Enforcement Report 5/11/2011 Class ll: PRODUCT UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: – Complete Blood...
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Company: Philips Medical Systems Date of Enforcement Report 5/4/2011 Class ll: PRODUCT MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to...
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Company: Gambro Renal Products, Inc. Date of Enforcement Report 5/4/2011 Class ll: PRODUCT Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Recall # Z-1901-2011 REASON Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure. RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro...
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Company: Hospira Inc. Date of Enforcement Report 5/4/2011 Class ll: PRODUCT GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; list 13092-04-01. A stand-alone PC application for administration of medications specific to the GemStar Infuser. Recall # Z-1999-2011 REASON The software enables programming of the GemStar device for a Bolus Lower Lockout...
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Company: Defibtech, LLC .Date of Enforcement Report 4/29/2011 Class l: Date Recall Initiated: March 14, 2011 PRODUCT Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. 65,885 AEDs distributed in the United States are subject to this recall. The 267 affected lots were distributed in February 2011....
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Company: Varian Medical Systems, IncDate of Enforcement Report 4/27/2011 Class ll: PRODUCT Varian Medical Systems, Varis Vision – RT Chart version 7.3.10. For radiation therapy. Model number H83. Recall # Z-1957-2011 REASON An issue with the Varis Vision software where treatment can occur without the dynamic Multileaf Collimator component and may deliver a higher than...
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Company: Siemens Medical SolutionsUSADate of Enforcement Report 4/20/2011 Class ll: PRODUCT Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461; The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional,...
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Company: GE Healthcare LLC Date of Enforcement Report 4/20/2011 Class ll: PRODUCT 1) GE Healthcare, CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients...
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Company: Quest Medical Inc. Date of Enforcement Report 4/20/2011 Class lll: PRODUCT Quest MPS and MPS 2 Consoles. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a...
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Company: GE Healthcare LLCDate of Enforcement Report 4/20/2011 Class ll: PRODUCT GE the CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE Monitor B850 host processing unit running the CARESCAPE Monitoring platform software, a display with integrated keyboard...
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Company: Hamilton Medical Inc Date of Enforcement Report 4/20/2011 Class ll: PRODUCT Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; Neonatal Software catalog number: 159700; Neonatal Option catalog number: 159187. Hamilton Medical Intended for use in the hospital and institutional environment where healthcare professionals provide...
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Company: Gambro Renal Products, IncDate of Enforcement Report 4/20/2011 Class ll: PRODUCT Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Recall # Z-1901-2011 REASON Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure. RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro Renal...
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FDA has created a webpage dedicated to regulation of Medical Device Data Systems. Note that the deadline for registration and listing (including for healthcare institutions that would be considered MDDS manufacturers) is May 18, 2011, and the deadline for reporting adverse events through MedWatch is April 18, 2012.
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT 1) ACUSON and SONOLINE Antares and Antares PE ultrasound systems at product versions 4.0 and 5.0 with cardiovascular options installed; ACUSON Antares 4.0 & 5.0: 10032747, 10037592, 10040728; ACUSON Antares PE 4.0 & 5.0: 10032746, 10037591, 10038202, 10040729; SONOLINE Antares 4.0 &...
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Company: Philips Medical Systems, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT 1) iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92; iSite PACS: iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system...
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Also for anatomical...
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Company: Ortho-Clinical Diagnostics.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT The enGenTM Laboratory Automation System consists of 3 main components including Instrument Management Subsystem (Instrument Manager), Automated Track Subsystem (TCAutomation) and Configuration File developed by Ortho-Clinical Diagnostics (OCD). The Instrument Manager is a Windows-based software product that operates on a Pentium-class (or higher) PC processor....
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system. a) Part No. 081239953, b) SPI Patch, Part No. 08164365. Recall # Z-1834-2011 REASON Software defect problem is repeatable.. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Concord, CA, by letter beginning...
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Company: Philips Medical Systems, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT AExtended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace?? (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of...
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Company: Philips Medical Systems, Inc.Date of Enforcement Report 4/13/2011 Class ll: PRODUCT Extended Brilliance Workstation (EBW) a component of the Computed Tomography 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 at different angles and planes; Model #728231. Recall...
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A proposal for a guidance document on “Applying the Quality System to Medical Device Data Systems” has been submitted to AAMI by the FDA. The work is expected to be done by the AAMI software committee and the AAMI Quality Management committee.
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The new work item proposal (NWIP) for a standard for “Healthcare Software Systems – Part 1: General requirements” was approved in IEC. 82304-1 62A 839 CD
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Company: Moog, Inc.Date of Enforcement Report 4/8/2011 Class l: Moog Incannounced today that the Food and Drug Administration (FDA) has classified the voluntary correction of the Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart, and PainSmart IOD as a Class I recall. The affected models were manufactured and updated from May 2007 to February 2011....
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Company: Philips Healthcare Inc.Date of Enforcement Report 4/6/2011 Class ll: PRODUCT Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. Used for the termination of ventricular tachycardia and ventricular fibrillation. Recall # Z-1609-2011 REASON Software: EtCO2 and Ventilation Rate...
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Company: QIAGENDate of Enforcement Report 4/6/2011 Class ll: PRODUCT Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation...
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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Boston, MA)

Multiple participants from the same company: If you register 5 or more from the same company before March 15, 2025, receive a special discounted registration of $1999 per person.  These registrations may be transferred to another person at any time. Email training@softwarecpr.com to register and secure the TEAM discount.

 

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

  • Americas: 11-13 February 2025
  • EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
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See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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