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/Docs/FDAClinicalTrialsComputerSystemGuidance-051007-04d-0440-gdl0002.pdf
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Company:Smiths Medical MD, Inc., . Date of Enforcement Report:5/2/2007 Class:ll PRODUCT Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4, Recall # Z-0768-2007 REASON Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump’s startup sequence when the pump’s Preventative Maintenance...
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/Docs/ComputerizedLaborMonitoringSystemClassificationRule042407.pdf
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/Docs/ComputerizedLaborMonitoringSystemGuidance042407.pdf
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RecipientG&B Electronic Designs Limited Product: Tracklt and NicoletOne Ambulatory Electroencephalograph Recorder devices Date:4/24/2007 Failure to assure that when computers or automated data processing systems are used as part of the production or quality system the manufacturer shall validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i)....
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Company:Radiometer America Inc. Date of Enforcement Report:4/11/2007 Class:ll PRODUCT ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27, Recall # Z-0705-2007 REASON In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific...
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Company:Smiths Medical MD, Inc., . Date of Enforcement Report:4/11/2007 Class:ll PRODUCT Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP); RX ONLY, Recall # Z-0718-2007 REASON The year of manufacture had been incorrectly entered as 1980 into the...
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Company:Pulse Biomedical, IncDate of Enforcement Report:4/11/2007 Class:ll PRODUCT QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine, Recall # Z-0716-2007 REASON No 510 (k) marketing clearance for the product. CODE Serial numbers: 4605AU0251E, 2306AU0600E-BT, 2306AU0601E-BT, 2406AU0610E-BT, and 2706AU0641E-BT. RECALLING FIRM/MANUFACTURER...
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The EU parliament reviewed the suggested changes to the Medical Device Directives including software related changes. The full Oct 2006 report is at the link provided. MDD
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Recipient:BTI Filtration Product: mixed bed deionization (DI) tanks and carbon tanks that are used to provide treated water to dilute dialysate for use in hemodialysis. Date:2/27/2007 Failure to ensure the device master record includes or refers to the location of the device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications, as required...
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Recipient:Seryx, lnc Product: Signature Genetics software program Date:2/22/2007 This letter is in response to the Food and Drug Administration’s (FDA’s) review of your web site www.seryx.com, and the information you provided to The Office oft Vitro Diagnostic Devices (OIVD) in FDA’s Center for Devices and Radiological Health in a telephone conference on May 23, 2006...
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Recipient: MRL, Inc.. Product: automatic external defibrillators Date:12/8/06 We have reviewed your response to FDA-483 Observation # 12 and conclude that the plan was adequate; but without completion of the databases we have no assurance that its implementation will be adequate. 10. Failure to have production and process controls for automated processes, as required by...
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Recipient:Edwards Life Sciences, LLC Product: Swan-Ganz Continuous Cardiac Output (CCO) Catheter, Vigilance Monitors, and stents Date:2/5/2007 Failure to submit a supplemental report to FDA within 1 month of receipt of information that was known to you regarding a serious injury reportable under 21 CFR 803.50, as required by 21 CFR 803.56. For example, b) A...
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Company:Boston Scientific Corp. Date of Enforcement Report:4/6/2007 Class:ll PRODUCT a) Product Description: HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system), Recall # Z-0687-2007; b) HTA Console System, 230 Volt, English, Product Number: 560010 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system), Recall #...
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Company:Siemens Medical Solutions Date of Enforcement Report:4/6/2007 Class:ll PRODUCT Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system, Recall # Z-0652-2007 REASON The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due...
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Company:GE OEC Medical Systems,Inc Date of Enforcement Report:4/6/2007 Class:ll PRODUCT InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body), Recall # Z-0704-2007 REASON Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software. CODE InstaTrak 3500 Plus...
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Company:bioMerieux, Inc., Date of Enforcement Report:3/28/2007 Class:ll PRODUCT BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, Recall # Z-0644-2007 REASON Bottle data is not sent to BacT/ALERT 3D instrument. CODE All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software). RECALLING FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC, by letter on December...
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/Docs/GE-ConsentDecree-Customer_Letter_1-15-07.pdf
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IEC 62A and ISO 210 balloting is complete and both approved the work item to initiate project number IEC 80002 Medical device software – Guidance on the application of ISO 14971 to medical device software. The first working group meeting will be in May in Germany. Depending on the direction this work takes it could...
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Company:Stentor Inc Date of Enforcement Report:3/21/2007 Class:ll PRODUCT The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data throughout a clinical environment, Recall # Z-0616-2007 REASON A defect may cause patient image orientation markers to be incorrectly labeled on...
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/docs/JMurrayPresentation-softwarecompliancescienceMarch2007.pdf
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Company:Beckman Coulter, Inc. Date of Enforcement Report:3/14/2007 Class:ll PRODUCT Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5), Recall # Z-0566-2007 REASON There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the...
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Company:Siemens Medical Solutions USA, Inc., Date of Enforcement Report:2/28/2007 Class:ll PRODUCT a) Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; part number 08717741, Recall # Z-0548-2007; b) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System with a Pinhole Collimator, Recall # Z-0549-2007 REASON Symbia systems, running...
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Company:Cyberonics, Incl Date of Enforcement Report:1/31/2007 Class:ll PRODUCT a) Cyberonics VNS Therapy System, Model 250-‘HAND HELD’ programming software v6.1, v6.1.7, v7.0 and v7.1.3, Recall # Z-0341-2007; b) Handhelds-Cyberonics VNS Therapy System, Model 2500-‘Handhelds’ preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3, Recall # Z-0342-2007 REASON During programming, pulse generator may be inadvertently set to...
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Company:GE Healthcare Integrated IT Solution Date of Enforcement Report:1/31/2007 Class:ll PRODUCT GE Centricity PACS RA 1000 Workstation; for diagnostic image analysis; Software versions 2.1.XX. and 3.0.XX. used in combination with the GE Senographe 2000D, Senographe DS or Senographe Essential, Recall # Z-0373-2007 REASON The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display...
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Company:Terumo Advanced Perfusion System 1 Date of Enforcement Report:2/7/2007 Class:ll PRODUCT Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046, Recall # Z-0381-2007 REASON Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and...
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Company:Beckman Coulter, Inc. Date of Enforcement Report:1/10/2007 Class:ll PRODUCT Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers, Recall # Z-0471-2007 REASON The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may...
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Company:Beckman Coulter Inc., Date of Enforcement Report:1/4/2007 Class:ll PRODUCT LFC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit, Recall # Z-0317-2007 REASON The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog...
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Company:Terumo Cardiovascular Systems Corp Date of Enforcement Report:1/5/2007 Class:ll PRODUCT a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763, Recall # Z-0314-2007; b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within...
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/docs/FDAComplementaryandAlternativeMedicineProductsDraft2006.pdf
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Company:St Jude Medical Date of Enforcement Report:12/27/2006 Class:ll PRODUCT a) St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510, Recall # Z-0296-2007; b) St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650, Recall # Z-...
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Company:Medtronic Emergency Response Systems, Inc., Date of Enforcement Report:12/27/2006 Class:ll PRODUCT LIFEPAK 20 automatic external defibrillator, Recall # Z-0295-2007 REASON LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power. CODE Devices with software version -028, -030, -032, and -038. RECALLING FIRM/MANUFACTURER Medtronic Emergency Response Systems, Inc., Redmond...
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Recipient: MRL Inc., a Welch Allyn Co..Product:Automatic external defibrillators Date:12/8/06 Failure to have production and process controls for automated processes, as required by 21 CFR 820.70(i). when computers or automated data processing systems are used as part of production or the quality system. A manufacturer is required to validate computer software for its intended use...
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Company:Data Innovations, Inc. Date of Enforcement Report:12/6/2006 Class:ll PRODUCT a) Roche Modular Drive (rchmdlri), analytical laboratory data interface, Recall # Z-0223-2007; b) Roche Cobas driver (rchcob6i), analytical laboratory data interface, Recall # Z-0224-2007 REASON Software of modular driver may incorrectly report patient results as Quality Control Results. CODE a) Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and...
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Company: Beckman Coulter Inc Date of Enforcement Report:11/29/2006 Class:ll PRODUCT Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1, Recall # Z-0197-2007 REASON Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube...
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Company:AGFA Corp., Date of Enforcement Report:11/29/2006 Class:ll PRODUCT CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405), Recall # Z-0219-2007 REASON Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on...
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Company:Data Innovations, Inc., Date of Enforcement Report:11/22/2006 Class:ll PRODUCT Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R), Recall # Z-0167-2007 REASON Patient results may be associated with an incorrect specimen. CODE Software Versions: 8:00, 8.01, 8.02, 8.03 or 8..04 RECALLING FIRM/MANUFACTURER Data Innovations, Inc., South...
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Sherman Eagles, a Medtronic Standards representative and co-chair of the AAMI software committee, gave a presentation on changes and new developments in software standards at the Nov 2006 Advamed conference. This presentation is at the link provided. It addresses the withdrawal of ISO/IEC 60601-1-4 and the incorporation of Programmable Electronic Medical Systems (PEMS) into the...
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/docs/IVDDFDARegulationofSoftwarePresentation1106.pdf
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/Docs/GERecallLetter9800_8800_6800Nov2007.pdf
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CompanyGuidant Corporation Date of Enforcement Report:11/1/2006 Class:ll PRODUCT Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators, Recall # Z-0002-2007 REASON Final software load did not occur prior to shipment of select programmers. CODE Serial numbers: 051089, 051449, 055130, 056463,...
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/docs/FDAPortableInvasiveGlucoseMonitoring-DraftGuidance102406.pdf
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Company:AGFA Corp., Date of Enforcement Report:10/18/2006 Class:ll PRODUCT CR DX-S, Image Intensified Fluoroscopic X-ray system, Recall # Z-0031-2007 REASON Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss. CODE Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below. RECALLING FIRM/MANUFACTURER Recalling...
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Company: Hitachi Medical Systems America Inc. Date of Enforcement Report:10/18/2006 Class:ll PRODUCT MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J, Recall # Z-0029-2007 REASON Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol,...
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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.

 

For private, in-house courses, please contact us.

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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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