Category

News
Company: Michigan Instruments Inc.Product: Thumper Model 1007 Mechanical CPR System Date: 3/23/04 You failed to perform or document the verification or validation of production process changes, such as the Inspiratory Time Test Specification, _____ on 12/17/2002 and the _____ software changes on 11/7/2000 (FDA-483 #11, c. and # 11, i) as required by 21 CFR...
Read More
The AAMI Software Risk Management Technical Information Report draft comment period ended March 1, 2004. Comments were generally positive.The next step is a working group meeting May 11-12, 2004 to resolve comments and do a final edit to prepare the document for formal ballot. Contact one of the co-chairs if you are not a member...
Read More
FDA has been investigating putting together information on hazards of various types of devices as an aide to both FDA and industry. Sandy Weininger at CDRH has established a forum for dissemination of information on this project. If you are interested in participating or receiving updates on this effort send email to office@softwarecpr.com or directly...
Read More
Company: American Red Cross Transplantation ServicesProduct: Cryopreserved heart valves Date: 3/11/04 The cryopreservation process dated 5/19/95, Computer Rate Controlled Freezer for Cryopreservation of Human Tissue, was not adequate. The validation included determining the maximum tolerance limits of the cryopreservation unit to freeze heart valves at a specified rate but only cryopreservation solution was used, not...
Read More
Company:Toshiba American Med SysDate of Enforcement Report: 3/10/04 Class: III PRODUCT Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models. Recall # Z-0546-04. REASON Software anomally causes image slices to be in incorrect order. CODE Flexart systems with software V3.51*R534 to V4.10*R551. Visart systems with software V3.51*R234 to V4.10*R251. Excelart systems with software V4.04*R251 to...
Read More
Company: Varian Medical SystemsDate of Enforcement Report: 3/10/04 Class: II PRODUCT EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader. Recall # Z-0582-04. REASON Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy CODE Serial numbers (Domestic units): 724 215 765 210 212...
Read More
Company: Health Directions Inc.Product: Health Pax Cranial Electrotherapy Stimulator Device Date: 3/4/04 -“Most recently, the dramatic evidence of the efficacy of CES entails use of computerized EEG’s or topographical brain mapping, validating that CES alters the abnormal electrophysiology associated with drug/alcohol abuse and other organic brain diseases as well as normalizing other dysfunctional brain wave...
Read More
Company: Soft Computer Consultants, Inc.Date of Enforcement Report: 3/3/04 Class: II PRODUCT “Softbank II” Laboratory Information System. Recall # B-0841-4. REASON Defects in the design of blood bank software program could result in incorrect patient laboratory records. CODE V.19, V.21, and V.22; Release 3.1.3. RECALLING FIRM/MANUFACTURER Soft Computer Consultants, Inc., Palm Harbor, FL, by telephone...
Read More
Company: Coherent, Inc.Date of Enforcement Report: 3/3/04 Class: II PRODUCT Quattro FAP System, Class IV multi-wavelength laser diode material processing machine. Recall # Z-0357-04. REASON Performance requirement-safety interlocks malfunction due to improper information included in the software operating the laser CODE None. RECALLING FIRM/MANUFACTURER Coherent, Inc, Santa Clara, CA, by technician visit to install software,...
Read More
Company: Ocuserv Instruments Inc.Product: Ultrasonic Imaging Systems, Autoscan DB 3000, DB 3000C Biometric Rulers and Ophthalmic A-Scan Systems Date: 3/2/04 During an inspection of your firm located in Jamaica, New York, conducted during the dates of January 13, 14 & 23, 2004, our investigator determined that your firm manufactures medical devices under the brand names...
Read More
Company: MedRx Inc.Product: “Otowizard” and “Vet Digitizer” Date: 3/1/04 Your firm failed to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality as required by 21 CFR 820.70(c). There was no electro-static discharge (ESD) procedures or other precautions in effect when electronic...
Read More
Company: GVI Technology PartnerDate of Enforcement Report: 2/18/04 Class: III PRODUCT CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version BIA. Recall # Z-0527-04. REASON Due to limitations in the operating software, the acquired scan may not be processed properly. CODE S/Ns: 100 thru 105, and 107 thru 116. RECALLING FIRM/MANUFACTURER GVI...
Read More
Company: Medtronic MiniMedDate of Enforcement Report: 2/18/04 Class: III PRODUCT Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software. Recall #Z-0531-04. REASON A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software. CODE All...
Read More
Company: Cerner CorporationDate of Enforcement Report: 2/11/04 Class: II PRODUCT Cerner HNA Classic Patient Management (U60)/Patient Linking (PHC) software, HNA Classic 306. Recall # B-0440-4. REASON Blood bank software, which included a defect that could result in the failure to accurately display all alloantibodies when linking or combining medical records for the same patient, was...
Read More
Company: Shanghai Medical Ltd.Product: Active pharmaceutical ingredients Date: 2/10/04 One of the discussion points with management concerned missing data for the analysis of [redacted] and [redacted] by [redacted] There were six entries in the [redacted] logbook that could not be found in the correlating computer files. The investigative team was together during the interaction with...
Read More
Company: Imaging Diagnostic Systems Inc.Product: Investigational device Date: 1/28/04 Monitors also failed to observe that the first enrolled patient’s…was assessed with an earlier software version. Because earlier software versions were not equivalent to later versions used in the study, the data should not have been included in the data analysis. Issuer: Center for Devices and...
Read More
Company: Respironics California Inc.Product: Espirit mechanical ventilator Date: 1/27/04 The design validation activities conducted for the Esprit ventilator software version 3.2 failed to ensure that the device conforms to the defined user/patient needs and intended uses [21 CFR 820.30]. Specifically: There was no documented evidence that any integration and throughput testing of the device was...
Read More
Company: Rocky Mountain Lions Eye BankProduct: Human corneas, sclera and whole eye globes Date: 1/26/04 Paragraph 12 of the Biohazardous Waste Disposal procedure includes the provision that the Quality Assurance (QA) staff will review and verify the documentation of destroyed tissue on the Destruction Log is consistent with the record entry in the chart and...
Read More
Company: General Electric Medical Systems Information TechnologyDate of Enforcement Report: 1/21/04 Class: II PRODUCT Solar 9500 Information Monitor. Recall # Z-0250-04. REASON Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first. CODE Software version 3A. RECALLING FIRM/MANUFACTURER General Electric Medical Systems Information Technology, Milwaukee,...
Read More
Company: Medtronic MiniMedDate of Enforcement Report: 1/21/04 Class: III PRODUCT Medtronic MiniMed. Model 7311 Solutions Pumps and Meters Software. Recall # Z-0265-04. REASON Accessory software fails to report certain reports following download of data from 712 pump. CODE Version 5.0A. RECALLING FIRM/MANUFACTURER Medtronic MiniMed, Northridge, CA, by visit or FedEx software on CD-rom beginning on...
Read More
Company: Misys Healthcare Systems.Date of Enforcement Report: 1/21/04 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-0235-04. REASON Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by facsimile...
Read More
Company: Roche Diagnostics Corp.Date of Enforcement Report: 1/21/04 Class: II PRODUCT a) Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R. Recall # Z-0326-04; b) Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R. Recall # Z-0327-04; Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and...
Read More
Company: Urologix, Inc., Date of Enforcement Report: 1/21/04 Class: II PRODUCT Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperplasia). The Prostatron utilizes a transurethral microwave antenna, with simultaneous urethral cooling, to heat the prostate. This heating process is regulated through feedback from...
Read More
The AAMI software committee is preparing comments on the “FDA Guidance for the Content of Premarket submissions for Software Contained in Medical Devices” in the interest of providing FDA input for future revision of this and related guidances. If you are not a member of the AAMI software committee and would like SoftwareCPR (a member...
Read More
Company: James Howe M.D. – University of Vermont College of MedicineProduct: Investigational device Date: 1/16/04 The x-rays and radiology report for patient [redacted] 24-month visit in 2002 were not included in the subject’s file. The patient’s Radiographic Evaluation form you signed on September 27, 2002, shortly after [redacted] 24-month visit was scheduled to take place,...
Read More
Company:Minolta Corp.Date of Enforcement Report: 1/14/04 Class: II PRODUCT a) Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger,...
Read More
Company: Information Data ManagementDate of Enforcement Report: 1/9/04 DATE RECALL INITIATED: January 9, 2004 PRODUCT / VERSIONS: IDM Surround System, Software versions 3.4, 3.5, and 3.6 REASON: IDM’s Surround System fails to recognize duplicate batches when used in conjunction with the Abbott PPC (Parallel Processing Center) and the TPC (Total Process Control) mode is utilized....
Read More
The AAMI Software Risk Management Technical Information Report working group has a full draft out for formal comment as of Jan 5, 2004. The comment period ends March 1, 2004. Contact one of the co-chairs if you are not a member of the AAMI committee and would like a copy for comment: Alan Kusinitz Managing...
Read More
Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 12/24/03 Class: II PRODUCT Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata Upgrade, Syngo Symphony, Syngo Symphony Q, and Syngo Symphony Upgrade. Model numbers 4772906, 7106995, 7104693, 5751438, 7106714, 7104719, 7106425, 7104594, 4772971, and...
Read More
Company: IND Diagnostic Inc.Product: Medical device Date: 12/23/03 Failure to establish and maintain procedures to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results as required by 21 CFR 820.72 (a). Issuer: Center for...
Read More
Company: Eldon Biologicals A/S.Product: Medical device Date: 12/23/03 Microsoft 2000 Excel spreadsheet software used manufacturing has not been validated for the purpose of generating a worksheet for formulation of reagents. No documentation was found to establish or verify corrections made to the program. Failure to validate computer software for its intended use according to an...
Read More
Company: Varian Brachytherary VirginiaDate of Enforcement Report: 12/17/03 Class: II PRODUCT BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Recall # Z-0176-04. REASON The manufacturer’s instructions for using radiation treatment software may cause healthcare practitioner to administer an incorrect treatment to...
Read More
Company: Misys Healthcare SystemsDate of Enforcement Report: 12/10/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0151-04. REASON Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modfy/Reject prompt will cause the order not to be processed by the system. CODE Versions 5.2, 5.23, 5.3 up to...
Read More
Company: Misys Healthcare SystemsDate of Enforcement Report: 12/10/03 Class: I PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-0007-04. REASON Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient’s chart without review. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by facsimile on August...
Read More
Company: Medron Inc.Product: Various catheters Date: 12/3/03 We are in receipt of your correspondence dated June 6, 2003 in response to the FD-483 issued at the conclusion of the inspection. Your response is inadequate in that all numbered items listed above were not addressed. However, we acknowledge that you have implemented some corrective action with...
Read More
The AAMI Software Risk Management Technical Information Report working group has completed a full draft for committee and public comment. Contact one of the co-chairs if you are not a member of the AAMI committee and would like a copy for comment: Alan Kusinitz Managing Partner of SoftwareCPR at alan@softwarecpr.com or Paul Jones of FDA...
Read More
Company: Biotronik, Inc.Date of Enforcement Report: 11/26/03 Class: II PRODUCT a) Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. Recall # Z-0076-04; b) Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. Recall # Z-0077-04. REASON Potential for early depletion of Implantable Cardioverter Defibrillator battery. CODE a) Serial Numbers: 7811xxxx;...
Read More
Company: Abbott Laboratories, IncDate of Enforcement Report: 11/19/03 Class: II PRODUCT AEROSET System Software, Catalog 2-95068-01 version 1.02ER000 and Catalog 2-95175-01 AEROSET System Software, version 1.02ER000 Upgrade Kit. Recall # Z-0091-04. REASON Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples. CODE Version 1.02ER000 and...
Read More
Company: General Electric Medical Systems Information Technology,Date of Enforcement Report: 11/19/03 Class: II PRODUCT Solar 8000M Patient Monitor. Recall # Z-0092-04. REASON Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display,...
Read More
Company: Veterans Health Administration Office of InformationDate of Enforcement Report: 11/19/03 Class: II PRODUCT VistA Blood Bank Software. Recall # B-0301-4. REASON Blood establishment computer software that could allow the release of unsuitable blood products was distributed. CODE Version number 5.2, software patch LR*5.2*301. RECALLING FIRM/MANUFACTURER Recalling Firm: Veterans Health Administration Office of Information, Hines,...
Read More
Company: Central Texas Regional Blood and Tissue CenterProduct: Blood products Date: 11/7/03 Specifically, one donor tested Nucleic Acid Test (NAT) HIV positive on a unit donated 4/4/2002. The donor donated a Whole Blood unit on 4/16/2002. The testing laboratory requested the Fresh Frozen Plasma (FFP) to be tested from the 4/16/2002 donation and all tests...
Read More
Company: Bayer Corp.Date of Enforcement Report: 11/5/03 Class: II PRODUCT Bayer Rapidpoint 405 Blood Gas Analyzer. Recall # Z-0066-04. REASON Potential for bias shift in p02 values due to air bubble in sample path. CODE Software Versions below 3.1. RECALLING FIRM/MANUFACTURER Bayer Corp., Medfield, MA, by telephone and letter dated September 26, 2003. Firm initiated...
Read More
On 10/23/03, Alan gave a presentation on risk based approaches to Part 11 as recommended in the final FDA guidance.  A copy of the slides are at the link provided. Also available on the site are the slides from Joe Famulare (FDA’s Part 11 lead) presented at this conference. scpred_AKusinitz-Part11AdvamedRiskslides102303
Read More
Guidance for Industry and FDA Staff Providing Regulatory Submissions in Electronic Format — General Considerations.  Document dated Oct 22, 2003. This guidance focuses on use of pdf files. It provides many specific requests in construction of the pdf for suitability for electronic submissions. These include resolutions, pagination, preference for digital instead of scanned source documents....
Read More
1 76 77 78 79 80 94

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.

Email training@softwarecpr.com for more info.

 


 

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
  • Southern Central Northeastern Pacific: 24-26 February 2025
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)

Next public offering:  TBD

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.