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Company: Respironics Novametrix, IncDate of Enforcement Report: 7/14/04 Class: II PRODUCT Linear accelerator workstation software suite. Recall # Z-1084-04. REASON An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1. CODE MLC Workstation...
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Company: Fischer Imaging CorpDate of Enforcement Report: 7/21/04 Class: II PRODUCT Fischer SenoScan True View Digital Mammography System. Recall # Z-1094-04. REASON Existing software may allow Image data to be truncated in the margin of the breast on processed patient images. CODE Product number 94829G-1, 94830G-1, 94830G-2. RECALLING FIRM/MANUFACTURER Fischer Imaging Corp, Denver, CO, by...
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Company: Siemens Medical Solutions USADate of Enforcement Report: 7/21/04 Class: II PRODUCT Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163. Recall # Z-1095-04. REASON The Image Navigator feature in the MagicView 300 VA42A or VA42B software may not be imported accurately to certain CT or MR...
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Company: Adac LabsDate of Enforcement Report: 7/21/04 Class: III PRODUCT Emission Computed Tomography System. Recall # Z-1079-04. REASON Software problems may cause the detector head to drift unexpectedly. CODE Model number 2163-3000A, 2163-3000B; 510K K011611. RECALLING FIRM/MANUFACTURER Adac Labs, Milpitas, CA, by letter on June 21, 2004. Firm initiated recall is ongoing. VOLUME OF PRODUCT...
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Company: Aap Implantate AGProduct: Orthopedic implants Date: 7/16/04 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), Automated Processes. The regulation under 21 CFR 820.70(i) requires that when computers...
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Company: Inceptio Medical Technologies LCProduct: “Punctsure Vascular Access Imaging Procedure Kits” and other ultrasonic vascular imaging systems and sterile accesories Date: 7/14/04 Failure to validate a process for which results cannot be fully verified by subsequent inspection or test, [21 CFR 820.75(a)]. Your sterilization process validation for the Punctsure Vascular Access Imaging Procedure Kits is...
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Company: Respironics Novametrix, IncDate of Enforcement Report: 7/14/04 Class: II PRODUCT Model 509M Pulse Oximetry Interface Module Software. Recall # Z-1049-04. REASON Audio alarm may fail to sound when Sp02 limits drop below the set limits. CODE Software versions 2.0 or 2.5. RECALLING FIRM/MANUFACTURER Respironics Novametrix, Inc., Wallingford, CT, by letter dated September 3, 2002...
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Company: Sechrist Industries, Inc.Date of Enforcement Report: 6/30/04 Class: II PRODUCT Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI. Recall # Z-1032-04. REASON Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all. CODE Ventilators with production serial numbers beginning with a...
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Company: John Sjoding AB Date: 6/29/2004 Product: dental endosseous implants and attachments Failure to have changes in documents reviewed and approved by an individual in the same function or organization that performed the original review and approval, as required by 21 CFR 820.40(b). For example, on October 16, 2003, the K.A. Rasmussen as. Document Number...
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Company: Roche Diagnostics CorpDate of Enforcement Report: 6/23/04 Class: I PRODUCT COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001. Recall # Z-1021-04. REASON The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong...
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Company: Beckman Coulter, IncDate of Enforcement Report: 6/23/04 Class: II PRODUCT DL 2000 Data Manager. Recall # Z-1027-04. REASON Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream. CODE Version 6.2. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letters on February 14,...
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Company: Radionics, Inc Date of Enforcement Report: 6/23/04 Class: II PRODUCT Radionics Head and Neck Localizer (HNL), Version B. Recall # Z-1020-04. REASON Software may provide inaccurate coordinates and cause mistreatment. CODE Serial Numbers: 032610023, 0326100023, 32690010, 041200023. RECALLING FIRM/MANUFACTURER Radionics, Inc., Burlington, MA, by telephone and letters dated May 25, 2004. Firm initiated recall...
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Company: CAS Medical Systems, Inc.Date of Enforcement Report: 6/23/04 Class: II PRODUCT Cardio Respiratory Monitor with Oximax technology with software version 5.0, Model 511. Recall # Z-1023-04. REASON Device may not alarm for %SpO2 value limit violations if a specific feature is enabled. CODE Serial Numbers: 0351320- through 0351369, 0413101through 0413107, 0413109,through 0413117, 0413119 through...
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The pdf at the link provided is a reprint of an article entitled “Understanding CAPA Requirements in a Software Context” authored by Alan Kusinitz, Managing Partner of SoftwareCPR, for the AAMI Biomedical Instrumentation and Technology journal published in the Spring of 2004. AAMI – AKusinitz CAPA – article 0504
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Company: Baxter Healthcare Renal DivDate of Enforcement Report: 6/16/04 Class: II PRODUCT a) HomeChoice and Yume Automated Peritoneal Dialysis Systems; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R. Recall # Z-1012-04; b) HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R. Recall # Z-1013- 04. REASON A software...
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Company: Hitachi Medical Systems America IncDate of Enforcement Report: 6/16/04 Class: II PRODUCT Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM Service Pack 1 and EZU-FC5W. Recall # Z-1005-04. REASON Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result...
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Company: Fujifilm Medical System USA, IncDate of Enforcement Report: 6/9/04 Class: III PRODUCT Fuji Flash IIP and CR-IR346CL Consoles. Recall # Z-0993-04. REASON Software: Incorrect measurement of objects within a CR image. CODE Versions A09-17 through A11-12. RECALLING FIRM/MANUFACTURER Fujifilm Medical System USA, Inc., Stamford, CT, by letter dated May 5, 2004. Firm initiated recall...
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Company: Philips Medical Systems Sales & Service Region No. AmericaDate of Enforcement Report: 6/2/04 Class: II PRODUCT Xcelera System, image processing, radiological. Recall # Z-0973-04. REASON Potential for the image data to be erased from the long term archive. CODE Part numbers: 9896 050 73251XC1.1L1, Software binder: 9896 050 73252XC1.1L1 Software binder + SP2. RECALLING...
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Company: Baxter Healthcare Renal DivDate of Enforcement Report: 5/19/04 Class: II PRODUCT a) Baxter Renal Software Suite (Renal Link and PD Link). Recall # Z-0901-04; b) Renalsoft software system. Recall # Z-0902-04. REASON There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to...
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Company: Beckman Coulter, Inc.Date of Enforcement Report: 5/19/04 Class: II PRODUCT Coulter LH750 Hematology Analyzer. Part Number 6605632. Recall # Z-0905-04. REASON If a customer enters a dilution factor for Sample B prior to the results from Sample A being transferred to the workstation, the predilute multiplication factor will be applied erroneously to the Sample...
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Company: Respironics California IncDate of Enforcement Report: 5/19/04 Class: II PRODUCT Esprit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics. Recall # Z-0903-04. CODE All codes. RECALLING FIRM/MANUFACTURER Respironics California Inc., Carlsbad, CA, by technician visit on or about June 1, 2001. Firm initiated recall is complete. REASON Ventilator would spontaneously suspend ventilatory support to...
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Company: Beckman Coulter, IncDate of Enforcement Report: 5/19/04 Class: II PRODUCT UniCel Dxl 800 Access Immunoassay System, P/N 973100. Recall # Z-0904-04. REASON Software coding error may cause a fatal error message. CODE All software versions prior to version 1.4. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letters on March 29, 2004. Firm initiated...
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Company: ADAC Laboratories, MadisonDate of Enforcement Report: 5/19/04 Class: II PRODUCT a) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-9052A-ENG. Recall # Z-0911-04; b) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-0613C-ENG. Recall # Z-0912-04; c) Pinnacle3 Radiation Therapy Planning System, Part Number 9104-2011A Rev. A. Recall # Z-0913-04; d) Pinnacle3 Radiation Therapy Planning System,...
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Company: Toshiba American Med Sys IncDate of Enforcement Report: 5/12/04 Class: III PRODUCT Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems. Recall # Z-0937-04. REASON Software anomaly. The region of the...
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Company: Efoora Inc. dba Virotek LLCProduct: Lancets and inoculating loops Date: 5/12/04 Your firm failed to validate computer software used as part of the quality system as required by 21 CFR 820.70(i). For example, your firm has no documented validation activities and results for the _____ electronic data management system. Your firm failed to establish...
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Company: Hudson Respiratory Care Inc.Date of Enforcement Report: 5/12/04 Class: II PRODUCT Concha IV Plus Heated Humidifier. Recall # Z-0929-04. REASON Software malfunction. CODE All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field. RECALLING FIRM/MANUFACTURER Hudson Respiratory Care Inc, Temecula , CA , by visit...
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/docs/CancelCellDetectionDeviceGuidance0904-Doc1531.pdf
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Date Recall Initiated: May 5, 2004 Product: Tecan Clinical Workstation configured with the Roche Diagnostics Amplicor CT/NG Analyzer Use: The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia and gonorrhea. Recalling Firm: Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46256-1025 Reason for Recall: A software error...
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Medical Device RecallsClass 1 Recall: Roche Diagnostics COBAS GUI Software for the Tecan Clinical Workstation Date Recall Initiated: May 5, 2004 Product: COBAS GUI Software Interface between the Tecan Clinical Workstation and the COBAS Amplicor Analyzer. Use: The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia and...
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Medical Device RecallsClass 1 Recall: Tecan Clinical Workstation with RoboNet Software Date Recall Initiated: May 3, 2004 Product: Tecan Clinical Workstation configured with the RoboNet Software. Use: The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia, gonorrhea and other tests. An operator controls the Tecan Clinical Workstation...
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Company: Hunterdon Medical CenterProduct: Biologics/Blood Date: 5/3/04 Failure to maintain accurate records which identify unsuitable donors so that products from such individuals will not be distributed, as required by 21 CFR 606.160(e). For example, in June 2003, it was discovered that all donor cards from the year 2000 were inadvertently destroyed. Without the original donor...
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This is one of the FDA recognized software standards.
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Company: Gyrus Medical, IncDate of Enforcement Report: 4/28/04 Class: II PRODUCT Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications. Recall # Z-0841-04. REASON The generator may malfunction when used in close proximity to a monopolar generator. CODE Model 744000....
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Company: Tri-Med Laboratories IncProduct: “PSE Carbinoxamine DM Syrup,” “Carbodex DM Syrup,” “Ronddamine DM Syrup” and other drugs Date: 4/28/04 Your investigation report for failing Pediahist lot F312 indicates that the batch was formulated superpotent because the manufacturing order sheet was reproduced from another product format on a computer, hence the incorrect amounts of ingredients were...
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Company: Abbott Laboratories, Inc.Date of Enforcement Report: 4/28/04 Class: II PRODUCT ARCHTECT System RS-232 Manual, product list number 06F71- 04, for the ARCHITECT i2000 Processing Module and the ARCHITECT C8000 Processing Module. Recall # Z-0818-04. REASON When using a LIS the software system will send up a test result of up to 20 characters although...
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Company: Positron CorpProduct: “POSICAM HZ,” “POSICAM HZL,” “mPower PET” and other Positron Emission Tomography diagnostic scanners Date: 4/26/04 The above-referenced service reports indicated that an upgrade was needed. There are no records attached or referenced in these service reports or clear descriptions to explain if the upgrade was due to a hardware design problem, a...
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Company: Medex, Inc.Date of Enforcement Report: 4/21/04 Class: III PRODUCT Medex 3000 Series Syringe Infusion Pumps. Recall # Z-0813-04. CODE Model numbers: 3010 (General use pump for use with 3cc to 60cc syringes, 3010a (Pump for use with 1 cc to 60cc syringes), 3010aE (Use with 1cc to 60cc syringes in UK), 3010aVX (Evaluation pump...
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Company: Spencer Technologies, Inc.Date of Enforcement Report: 4/21/04 Class: II PRODUCT Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the same hardware and software – the change from TCD 100M to PMD 100 is a marketing change)....
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Company: Surgilight IncProduct: Optivision Laser System Date: 4/20/04 Validation of Borland Compiler is incomplete because software used to control passwords was not addressed (FDA 483, Item #3) Complaint #17 dated December 17, 2001, references software locked up due to possible computer time and/or patient file recreation. Failure not determined Your firm’s design validation failed to...
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Company: Able Laboratories Inc.Product: Lithium, methylphenidate, phentermine and other drugs Date: 4/19/04 The MedWatch forms which you submitted were on FDA form 3500, which is for the voluntary reporting of ADEs by healthcare workers and consumers. As a drug manufacturer, you must be reporting all domestic ADEs on FDA MedWatch form 3500A. Reports of foreign...
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Company: Cordis Corp.Product: “Cypher Sirolimus-Eluting Coronary Stent” Date: 4/1/04 Failure to adequately validate for its intended purpose and according to an established protocol computer software used as part of the production or quality system, and failure to document validation activities and results, as required by 21 CFR 820.70(i). The automated _____ data acquisition system, used...
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Recipient:Cordis Corporation Product: Sirolimus-Eluting Coronary Stent Date: 4/1/2004 Failure to validate with a high degree of assurance, processes, including changed processes, that cannot be fully verified by subsequent investigation and test, as required by 21 CFR 820.75(a) & (c). For example: The automated [redacted] data acquisition system, used to ensure the integrity of the analytical...
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Company: General Electric Medical Systems Information TechnologyDate of Enforcement Report: 3/31/04 Class: II PRODUCT PatientNet Monitoring System – PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx. Recall # Z-0727-04. REASON Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly. CODE All PatientNet Central Stations. RECALLING FIRM/MANUFACTURER General...
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Company: Instrumentation Laboratory CoDate of Enforcement Report: 3/31/04 Class: II PRODUCT a) ACL Futura Instrument Analyzer. Recall # Z-0736-04; b) ACL Advance Instrument Analyzer. Recall # Z-0737-04. REASON Software may cause instrument to omit step causing reagent carryover which may effect patient test result. CODE a) Software prior to Version V3-5; b) Software version prior...
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Company: Siemans Medial Solutions USA, Inc CoDate of Enforcement Report: 3/31/04 Class: III PRODUCT Acuson Cypress Echocardiography System. Catalog number 8264604; Recall # Z-0744-04. REASON Software problem – mode does not appear on screen. CODE Serial numbers 73480 through 73535, 71165, 71561, 72532, 73125, and 73292. RECALLING FIRM/MANUFACTURER Siemans Medial Solutions USA, Inc, Plymouth Meeting,...
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Company: Coherent Inc Laser GroupsDate of Enforcement Report: 3/24/04 Class: I PRODUCT Coherent brand Quattro Diode Laser Systems; A Quattro FAP System. Recall # Z-0357-04. REASON Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated. CODE Serial Numbers/Model Numbers: TFAP0004P-TFAP00048. RECALLING FIRM/MANUFACTURER Coherent Inc...
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Company: Beckman Coulter IncDate of Enforcement Report: 3/24/04 Class: II PRODUCT a) CXP software, Part No. 623560. Recall # Z-0635-04; b) Cytomics MXP Software, Part No. 623688. Recall # Z-036-04; c) Cytomics RXP Software, Part Numbers: 175488, 6418489, 175260, 175261, 175262, 175263, 175264, 175265. Recall # Z-0637-04. REASON Software anomaly. Sample ID and the Run...
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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
  • 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
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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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