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Company: Draeger Medical, IncDate of Enforcement Report 11/5/2008 Class:ll PRODUCT Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300, Recall # Z-0202-2009 REASON May experience an interruption of ventilation for approximately 5 seconds. RECALLING FIRM/MANUFACTURER Recalling Firm: Draeger Medical, Inc., Telford, Pa, by letter dated September 2008. Manufacturer:...
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Company: Varian Medical Systems Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy from...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Acuson X300 ultrasound systems, ultrasound system with onscreen display. Model numbers 10037409, 10038837, 10348531. Potentially affected, but no volume currently: 10132987, 10133170, 10348532, 10348533, Recall # Z-0111-2009 REASON Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/5/2008 Class:ll PRODUCT Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02 ultrasound system with onscreen display, Recall # Z-0086-2009 REASON Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA,...
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The 1998 2nd edition of the standard UL 1998 Software in ProgrammableComponents was reaffirmed and reissued Oct 28, 2008. There were no substantive changes. This is one of the few software standards recognized by FDA.
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Company: Philips Medical Systems Date of Enforcement Report 10/29/2008 Class:lll PRODUCT Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) Revision: B.02.07 Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient, Recall # Z-2369-2008 REASON Software: If Weight Limits...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/29/2008 Class:ll PRODUCT Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system. Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479, Recall # Z-2468-2008 REASON As a result of bugs and calculation errors,...
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Company: Medtronic Neuromodulation Date of Enforcement Report 10/22/2008 Class:lll PRODUCT a) Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF;...
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Company: Cardinal Health NeuroCare Division Date of Enforcement Report 10/22/2008 Class:ll PRODUCT NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central...
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Recipient: Steris Isomedix Inc Product:sterilizes medical devices. Date: 9/25/2008 We have reviewed your response dated July 16, 2008, and have concluded that it is inadequate because while you have opened a Correction and Preventative Action (CAPA) to address this issue, your corrective actions did not address any product that was processed prior to the initiation...
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Recipient: Encore Medical, LP Product:muscle stimulators and ultrasound devices. Date: 6/25/2008 1. Failure to establish and maintain adequate procedures to identify actions(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example, your firm failed to identify the action(s) needed to correct failures and...
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Company: VISX Inc., a Subsidiary of AMO, Inc. Date of Enforcement Report 10/15/2008 Class:ll PRODUCT AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The device is used in conjunction with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery...
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Company: Abbott Laboratories Date of Enforcement Report 10/15/2008 Class:ll PRODUCT ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity, Recall...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/15/2008 Class:ll PRODUCT Acuson CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with Software revisions less than 4.0.0b, material number 784539, 7848521, and 7848547. Is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential...
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Company: Hologic, Inc., Date of Enforcement Report 10/15/2008 Class:ll PRODUCT a) Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment,...
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Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 10/8/2008 Class:ll PRODUCT GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis, Recall # Z-2183-2008 REASON When using any vessel analysis protocol of the AW Suite Card IQ application, the software can reload...
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Company: Varian Medical Systems Oncology Systems Date of Enforcement Report 10/8/2008 Class:ll PRODUCT Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48, Recall # Z-1612-2008 REASON A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan. RECALLING FIRM/MANUFACTURER Recalling Firm: Varian Medical Systems Oncology Systems, Palo...
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Company: SCC Soft Computer Date of Enforcement Report 10/8/2008 Class:ll PRODUCT SoftPath ASCII Software Releases 1.2, 2.1, 2.2 and 2.3, Recall # Z-2463-2008 REASON In the creation of revised report and supplemental reports diagnosis, text was inserted from another case. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwater, FL, by letter beginning February 23, 2006. Firm initiated...
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Company: Abaxis Inc. Date of Enforcement Report 10/8/2008 Class:ll PRODUCT a) Piccolo Chemistry Analyzer software version 6.121. Model Number 400-1028 in polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a single-use self- contained reagent disk, intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination., Recall # Z-2286-2008; b) Piccolo Chemistry...
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Company: SCC Soft Computer Date of Enforcement Report 10/8/2008 Class:ll PRODUCT SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases, Recall # Z-2329-2008 REASON Loss of text misrepresented individual tissue diagnosis on the final diagnosis print...
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Company: Varian Medical Systems Oncology Systems Date of Enforcement Report 10/8/2008 Class:ll PRODUCT Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments, Recall # Z-2308-2008 REASON Software anomaly in which swapping IDs of planning fields can produce inconsistencies between dose matrix and field parameters. RECALLING...
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Company: GE Healthcare Date of Enforcement Report 10/1/2008 Class:ll PRODUCT GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis, Recall # Z-1822-2008 REASON Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The...
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Company: Accuray, Inc Date of Enforcement Report 10/1/2008 Class:ll PRODUCT CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher, Recall # Z-2056-2008 REASON Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be...
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Company: Abbott Laboratories Date of Enforcement Report 10/1/2008 Class:ll PRODUCT ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, Part #7-201738-01; v2.20DB, Part #7-201738-02; v2.60, Part #7-203715-01; v3.10, Part #7-203715-02; 3.11, Part 7-203715-03; and 3.12. The Abbott ARCHITECT cSystem is designed to perform automated, random access, clinical chemistry...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/1/2008 Class:ll PRODUCT Radiation therapy system – PRIMEVIEW 3i System 2.1 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147675. Medical charged particle Radiation therapy system, part of the firm’s beam limiting device/accessory. The product provides data processing, and the SYNGO standard...
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Company: GE Healthcare Date of Enforcement Report 10/1/2008 Class:ll PRODUCT GE Healthcare Definium 8000 Digital Radiographic System, Recall # Z-1882-2008 REASON Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety. Occasional...
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Company: Intuitive Surgical, Inc, Date of Enforcement Report 9/24/2008 Class:ll PRODUCT Intuitive Surgical DA Vinci Surgical System, Mode; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02. The IS2000 CPG is used during cardiac ablation procedures, Recall # Z-1811-2008 REASON The product has a software interface problem. When the product is connected to the...
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Company: Sunquest Information Systems, Inc., Date of Enforcement Report 9/24/2008 Class:ll PRODUCT Sunquest Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory 6.1 and 6.2 and Sunquest Blood Bank and Blood Donor version 6.0.2 distributed with Sunquest Laboratory 6.3, Recall # B-2039-08 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER...
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Company: Philips Medical Systems Date of Enforcement Report 9/24/2008 Class:ll PRODUCT EasyVision RAD – Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW R4 2V2L6, and SW R4 2V2L7. The EasyVision RAD consists of a computer with digital interfaces, one or two (optional) monitors with keyboard...
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Company: Sunquest Information Systems, Inc., Date of Enforcement Report 9/24/2008 Class:ll PRODUCT Sunquest Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory 6.1 and 6.2; Sunquest Blood Bank and Blood Donor version 6.0.2 distributed with Sunquest Laboratory 6.3, Recall # B-2052-08 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER Sunquest...
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Company: CAS Medical Systems, Inc, Date of Enforcement Report 9/24/2008 Class:ll PRODUCT 740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN. Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric...
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Company: Intuitive Surgical, Inc., Date of Enforcement Report 9/24/2008 Class:ll PRODUCT da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, Recall # Z-2204-2008 REASON Defective software chip may cause the system to fail and lock up. RECALLING FIRM/MANUFACTURER Intuitive Surgical, Inc., Sunnyvale, CA, by letters, telephone and service visits beginning June 1,...
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Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 9/17/2008 Class:ll PRODUCT GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic image analysis; Recall # Z-1825-2008 REASON Incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or...
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Company: GE Healthcare Integrated IT Solutions Date of Enforcement Report 9/17/2008 Class:ll PRODUCT GE Centricity PACS RA1000 Workstation; for diagnostic image analysis; Recall # Z-1826-2008 REASON A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis. RECALLING FIRM/MANUFACTURER...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 9/17/2008 Class:lll PRODUCT a) ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 5937011 or 3-Scape Real Time Imaging, UPG ACU, PN 10033688. Material number 10032746, 10037592, 10032746, 10037591 or 10038202; Recall...
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Company: Stryker Endoscopy Date of Enforcement Report 9/17/2008 Class:ll PRODUCT Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system, Recall # Z-1316-2008 REASON Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur...
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Company: MIMvista Corp Date of Enforcement Report 9/17/2008 Class:ll PRODUCT MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone software package which operates on Windows 2000/XP; Recall # Z-1827-2008 REASON In MIM (4.0.2-4.0.5) and MIM (4.1.0-4.1.2) versions, there is an error that may occur...
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https://www.softwarecpr.com/Docs/JohnMurraySlides-IEC62304-091508.pdf
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Company: Physio Control, Inc Date of Enforcement Report 8/23/2008 Class:l PRODUCT LifePak CR Plus Automated External Defibrillator Product Number: 3200731-003 and 3200731-027 This device was manufactured from May 20, 2004 through August 11, 2007 and distributed from May 20, 2004 through December 4, 2007. REASON The AED instructs the responder, by voice prompts, to press...
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Recipient: Stratec Medizintechnik Gmbh Product: bone densitometer. Date: 9/10/2008 Failure to adequately document acceptance activities, as required by 21 CFR 820.80(e). For example: The printouts contained in the DHR derived from computer software used to calibrate and test the finished device do not include the name of individual or contain the signature of the individual...
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Recipient: Mavidon Medical Products Product:Class II Mavidon Medical Electrode Jelly. Date: 8/8/2008 7. Failure to validate, according to an established protocol, computer software for its intended use, when that software is used as part of the Quality System or part of production as required by 21 CFR 820.70(i). The regulation under 21 CFR 820.70(i) requires...
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Company: Philips Medical Systems Date of Enforcement Report 9/3/2008 Class:ll PRODUCT General X-Ray System types with Digital Spot Imaging (DSI) software. Software version: rel 6, Recall # Z-2160-2008 REASON X-ray images may be stored in the wrong patient file or corrupted; images from two different patients may be combined in one patient’s folder or may...
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Company: TomoTherapy Inc. Date of Enforcement Report 9/3/2008 Class:ll PRODUCT TomoTherapy Hi-Art System with software versions 3.0 and 3.1 – Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy, Recall # Z-1615-2008 REASON In certain cases of HI-ART Systems operating...
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Company: Philips Medical Systems Date of Enforcement Report 9/3/2008 Class:ll PRODUCT a) CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It...
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Company: Pride Mobility Products, Corp Date of Enforcement Report 9/3/2008 Class:ll PRODUCT Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107, Recall # Z-1776-2008 REASON Software – Watch dog timer feature was disabled RECALLING FIRM/MANUFACTURER Pride Mobility Products, Corp., Exeter, PA, by letter...
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Company: Baxter Healthcare Corp Date of Enforcement Report 9/30/2008 Class:ll PRODUCT Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter’s pharmacy compounders. The software assists the pharmacist in management...
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Company: Sunrise Medical, Inc Date of Enforcement Report 9/3/2008 Class:ll PRODUCT a) Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10, Recall # Z-1531-2008; b) Quickie Groove Power Wheelchair with QC (non-expandable) electronics, Model number EIPW13, Recall # Z-1532-2008 REASON Product experiences a longer than expected stopping distance, which may cause injury to...
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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)

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

Lead Instructor: Mike Russell

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  • Americas: 11-13 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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