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Recipient: Ronald G. Crystal M.D.Product: Investigational biologic products Date: 9/23/02 Subject _____ was enrolled in the study without Computerized Tomography (CT) documentation of the number of _____ present at the time of enrollment. Section 3.2 of the protocol requires that the subject have two or more _____ detected by CT scan. Issuer: Center for Biologics...
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Company: Misys Healthcare Systems IncDate or Enforcement Report: 9/18/02 Class: II PRODUCT Misys Laboratory. Recall # Z-1281-2. REASON Software anomaly regarding cell counts. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems Inc., Tuscon, AZ, by fax on April 23, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 469. DISTRIBUTION...
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Company: Mysis Healthcare Systems, IncDate of Enforcement Report: 9/18/02 Class: II PRODUCT Misys Commercial Laboratory. Recall # Z-1318-2. REASON Software anomaly. If the deformatter begins to process data prior to all patient result records or orders being extracted from the flat files, the remaining results or orders will not be extracted. This can result in...
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Company: Mysis Healthcare Systems, Inc.Date of Enforcement Report: 9/18/02 Class: II PRODUCT Mysis Commercial Laboratory. Recall # Z-1285-2. REASON Software anomaly: a result for an accesion number came across the interface as negative but should have been Do Not Result (DNR). CODE Versions 3.2.0; 3.2.2; 3.2.3, 3.3.0, 3.3.1a, 3.3.1, 3.4.0, 3.4.1b, and 3.4.1a. RECALLING FIRM/MANUFACTURER...
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Company: University of Massachusetts Memorial Medical Center.Product: Blood products Date: 9/12/02 In no more than fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps you have taken to correct these violations and to prevent them from recurring. Your response should also indicate the status of the...
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/docs/FDAPart11DraftArchivingGuidance00d-1539-nad0001.pdf
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Company: Unit Dose Packaging Inc.Product: Drug products Date: 8/29/02 Failure to establish a written procedure to calibrate, inspect, and check automated, mechanical, or electronic equipment used to manufacture drug products to assure proper performance. [21 CFR 211.68 (a)]. Specifically, there is no data to demonstrate that production equipment (two mixers, one filler, a water system)...
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Company: Diasorin IncDate of Enforcement Report: 8/28/02 Class: II PRODUCT Medusa software, DiaSorin Part 15794, for an OMNI (automated microtiter plate) Instrument used for the ETI-HA-IGMK Plus Enzyme Immunoasay for the Detection of IgM Antibody to Hepatitis A Virus in Human Serum or Plasma. Recall # Z-1265-2. REASON As a result of a software error,...
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Company: Roch DiagnosticsProduct: Accu Check Inform Blood Glucose System Class II Date of Enforcement Report: 8/28/2002 All units that have ever displayed a temperature icon in conjunction with patient use. Reason: May give erroneous results if the temperature icon has ever been displayed with use. Manufacturer: Roch Diagnostics, Mannheim, Germany. Recalled by: Roche Diagnostics Corporation,...
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Company: Dade Behring, IncDate of Enforcement Report: 8/21/02 Class: II PRODUCT Dimension(R) Xpand software revision 6.0.1 and 6.1 (Clinical Chemistry Analyzer). Recall # Z-1226-2. REASON The sample probe does not accurately track the fluid level. CODE Xpand software revision 6.0.1 and 6.1. RECALLING FIRM/MANUFACTURER Recalling Firm: Dade Behring, Inc., Newark, DE, by telephone on May...
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Company: Bayer CorporationDate of Enforcement Report: 8/21/02 Class: III PRODUCT Brand Name: ADVIA Centaur(R) Analyzer. Recall # Z-1233-2. REASON Software programming error. CODE All serial numbers distributed with Model/Part Number 572561, along with all existing software versions from 2.1 to 2.5. RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corporation, Business Group Diagnostics, Tarrytown, NY, by letter on...
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Company: University Hospitals of ClevelandProduct: Blood products Date: 8/19/02 With respect to your response to FDA-483 item #2, you stated that you will institute a computer change. We expect that changes to the computer system should be validated. Please provide documentation of the validation for this new change. Additionally, please explain what actions and/or retraining...
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On August 14, 2002, the HIPAA final privacy rule 45 CFR Parts 160 and 164 were modified to respond to comments and to reduce the administrative burden of the rule.  A copy of the new rule can be view here:  HIPAA Modified Final Privacy Rule 2002-08. Medical Device manufacturers that produce devices that will maintain patient...
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Company: Siemens Medical Solutions USADate of Enforcemet Report: 8/14/02 Class: I PRODUCT e.soft software version 2.0 used on all E.CAM Emission Imaging Computed Tomography Systems with e.soft A or e.soft A/P nuclear medicine workstations. Recall # Z-1189-2. REASON Incorrect image time stored for static images resulting in incorrect results. CODE e.soft software version 2.0 installed...
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Company: Baxter Healthcare CorpDate of Enforcement Report: 8/14/02 Class: I PRODUCT Logix-CM Compounder Software. Recall # Z-1203-2. REASON Software allows ingredient concentration errors during compounding. CODE Catalog #2M8400, Logix-CM software version 1.0.2. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL, by telephone on June 18, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...
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http://www.fda.gov/ohrms/dockets/dockets/00d1538/00d1538.htm
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Company: Philips Medical SystemsDate of Enforcement Report: 8/7/02 Class: II PRODUCT 1.5T MR Systems with software version R7.1.2 and higher: Magnetic Resonance Systems are indicated for use as diagnostic devices that produce transverse, sagital, coronal and oblique cross-sectional images, spectroscopic images and/or spectra based upon 1H and 31P metabolites, and that display the internal structure...
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Company: Semens Medical SystemsDate of Enforcement Report: 7/31/02 Class: II PRODUCT SONOLINE Antares, Diagnostic Ultrasound System. The SONOLINE Antares is a high-resolution, digital, broadband diagnostic ultrasound imaging system. It supports the following diagnostic applications: abdominal, OB/GYN, small parts, musculoskeletal, vascular, and urology. Recall # Z-1162-2. REASON Software anomalies that affect measurement and calculation data. CODE...
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Company: Philips Medical Systems Date of Enforcement Report: 7/31/02 Class: II PRODUCT Intera 1.0T and 1.5T MR Systems Magnetic Resonance Systems are indicated for use as diagnostic devices that display the internal structure and/or function of the head, body or extremeties. The coils are used to obtain optimal imaging. Recall # Z-1147-2/Z-1148-2. REASON Higher than...
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Company: Baxter Healthcare CorpDate of Enforcement Report: 7/31/02 Class: II PRODUCT Baxter Ipump Pain Management System infusion pump, product codes 2L3107 and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1166-2. REASON Software anomaly allows access to change prescription or program bolus without security. CODE Product codes 2L3107 and 2L3107R, all serial numbers. RECALLING FIRM/MANUFACTURER...
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Company: Earlham CollegeDate: 07/29/2002 Product: Prenatal vitamins In addition to the above listed violations, our Investigator noted that the laboratory is using an electronic record system for processing and storage of data from the atomic absorption and HPLC instruments that is not set up to control the security and data integrity in that the system...
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Company: Fresenius Medical CareDate: 7/25/02 Product: Naturalyte Acid Concentrate Your firm failed to validate the new salt delivery system for process deviation 2002-005 dated February 1, 2002 for Naturalyte Acid Concentrate lot 2B0017 as required by 21 CFR 820.75. Furthermore, the new computer software included with the new salt delivery system is not validated for...
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Company: Abbott LaboratoriesDate: 7/19/02 Product: Drug products including Biaxin and Meridia FDA compared the MedWatch forms in your computer to your paper files, and this comparison revealed inaccurate data in serious and unexpected adverse drug experience reports submitted to FDA. These inaccurate reports are a violation of 21 CFR 314.80(c)(1)(i). FDA District: Chicago District Office
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Company: Philips Medical SystemsDate of Enforcement Report: 7/3/2002 Class: II PRODUCT Information Center System and Upgrades as follows: a) M3150A Agilent or Virida Information center. Recall # Z-1119-2; b) M3151A Agilent or Virida Information Center Client. Recall # Z-1120-2; c) M3153A Agilent or Virida Surveillance Center. Recall # Z-1121-2; d) M3150AU#A01 Agilent or Virida Information...
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Company: Varian Medical Systems, Inc Date of Enforcement Report: 7/3/2002 Class: II PRODUCT Varian Medical System’s Eclipse VERSION 6.5 software, a proprietary application for Varian Vision ™ imaging systems. Recall # Z-1109-2. REASON Radiation treatment planning software malfunction could result in incorrect treatment regimen. CODE Eclipse software, version 6.5, Serial Numbers: 0016 0018 0022 0034...
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Company: Toshiba America Medical Systems, IncDate of Enforcement Report: 6/26/02 Class: II PRODUCT NEMIO, SSA550A, Diagnostic Ultrasound System. Recall # Z-0923-2. REASON Software anomally caused error in calculating VM_P. CODE Serial Numbers: B1552349 C1572413 C1572414 C1572415 C1572417 C1572418 C1572420 C1572423 C1572428 C1572429 C1572430 C1572431 C1572432 C1572433 C1572421. RECALLING FIRM/MANUFACTURER Toshiba America Medical Systems, Inc., Tustin,...
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483Company: American Red Cross City and Sate: Baltimore, MD FDA District: Baltimore, MD Dates of Inspection: 4/22-6/21/02 4. Failure of the quality control unit to determine root cause and prevent recurrence of significant deviations related to BSD 73.200M, “Shipping” version 1.7 January 2001. Between October 22, 2001 and April 23, 2002, the Chesapeake Region recorded...
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Company: Advanced Sterilization ProductsDate: 6/19/2002 Class: II PRODUCT STERRAD 100S Sterilization System. Recall # Z-1082-2. REASON Software anomaly allows half cycle run when full cycle displayed. CODE Version 3 or lower is subject to upgrade. Newer versions contain software “fix”. Current version is Version 6. RECALLING FIRM/MANUFACTURER Advanced Sterilization Products, Irvine, CA, by letters sent...
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/docs/NEMAPart11DraftValidationGuidanceComments.pdf
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Company: Liebel-Flarsheim CoDate of Enforcement Report: 5/29/2002 Class: II PRODUCT Liebel-Flarsheim Angiomat Illumena Media Power Injectors, P/N 900001, using Version 8.0 software with new console. Recall # Z-1046-2. REASON Pushing the scoll button repeatedly / rapidly results in erroneous protocol ID. CODE Serial Numbers: 0202-5000 to 0402-5126. RECALLING FIRM/MANUFACTURER Recalling Firm: Mallinckrodt, Inc. / Liebel-Flarsheim...
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Company: Fujifilm Medical Systems U.S.ADate of Enforcement Report: 5/29/02 Class: II PRODUCT Synapse Image and Information Management System. Recall # Z-1045-2. REASON Rotated/flipped Images not viewed on the screen may not rotate but left / right markers will be flipped. CODE Synapse Image and Information Management System with software versions 2.0.2 and 2.1.1. RECALLING FIRM/MANUFACTURER...
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http://hissa.nist.gov/effProject/handbook/c++/
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Company: Sigma International MedinaDate of Enforcement Report: 5/8/02 Class: II PRODUCT Sigma 8000 Volumetric Infusion Pumps with software version 3.50.01. Recall # Z-0991-2. REASON Software error: Distal occlusions may not be detected (no alarm) at rates above 550 ml/hr. CODE The following serial numbers. 49105, 49111R, 49188R, 49288R, 49289R, 49402R, 49436R, 49448R, 49454R, 49466R, 49507R,...
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Company: Roche Diagnostics CorpDate of Enforcement Report: 5/1/02 Class: II PRODUCT All DataCare Systems Software, as follows: Recall # Z-0960-2/Z-0974-2. a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200; b) DataCare ABG Data Management System for use in a blood gas point of care testing...
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Company: Philips Medical SystemsDate of Enforcement Report: 5/1/2002 Class: III PRODUCT Integris H5000, Angiographic X-ray system. Recall # Z-0924-2. REASON System may occasionally re-boot during a patient examination. CODE Units with SYSCO software version 11.1.2. RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated November 14, 2001., Manufacturer: Philips...
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Company: Hitachi LtdDate of Enforcement Report: 5/1/02 Class: II PRODUCT Roche Modular Analytics immunoassay based clinical chemistry analyzer, model E170, catalog number 7656961. Recall # Z-0922-2. REASON Possibility of false negative and false positive results being reported. CODE All units with software version 01-03. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter...
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Company: Sunquest Information systems, aka Misys HealthcareDate of Enforcement Report: 5/1/02 Class: II PRODUCT Misys Laboratory Microbiology Module, Recall # Z-0916-2. REASON Software does not allow comments to be shown in some reports. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information systems, aka Misys Healthcare, Tucson, AZ. Firm initiated recall is ongoing. VOLUME...
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Company: St. Gobain Ceramiques Avancees DesmarquestProduct: Medical Devices Date: 4/26/02 You need to property validate the … furnace process. Please supply a complete proposed validation protocol for the … furnace. This protocol should specifically address if any aspect of this furnace is computer controlled and how the software will be validated. Enclosed are copies of...
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Company: Zoll Medical CorpDate of Enforcement Report: 4/24/02 Class: I PRODUCT a) Zoll M Series Advisory Defibrillator. Recall # Z-0893-2; b) Zoll M Series AED Defibrillator (semi automatic defibrillator). Recall # Z-0894-2. REASON Defibrillator may fail to detect ventricular fibrillation and fail to deliver shock. CODE a) Serial Numbers: T98F00046-T01K27762 with System Software Version below...
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Company: Sunquest Information Systems, IncDate of Enforcement Report: 4/24/02 Class: II PRODUCT Misys Laboratory for Windows version 5.3. Recall # Z-0888-2. CODE REASON Software QA code of BOTH for patient sex can result in QA flags not being generated for abnormal results. Versions 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., aka Misys Healthcare Systems Tucson,...
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A NEMA presentation on HIPAA medical device issues is available here:  NEMA HIPAA Med Dev Issues Presentation. SoftwareCPR® provides on-site and web based training in HIPAA privacy and security regulations, in addition to other regulatory consulting services. SoftwareCPR® also provides a HIPAA Roadmap with links to relevant educational documents to paid subscribers (See Post HIPAA Privacy and...
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A NEMA paper on HIPAA medical device remote service issues is available here: NEMA HIPAA Med Dev Remote Services Paper. SoftwareCPR® provides on-site and web based training in HIPAA privacy and security regulations, in addition to other regulatory consulting services. SoftwareCPR® also provides a HIPAA Roadmap with links to relevant educational documents to paid subscribers (See...
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A NEMA paper on HIPAA is available here:  NEMA HIPAA Security Intro Overview. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was signed to law on July 21, 1996, and has the general objectives to: Guarantee health insurance coverage of employees Reduce health care fraud and abuse Introduce/implement administrative simplifications in order to augment...
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On December 28, 2000, a final privacy rule 45 CFR Part 160 and 164 was issued.  HHS provides the rule and related guidance here: https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html. Medical device manufacturers that produce devices that will maintain patient data should be aware of HIPAA privacy and security requirements to assure appropriate features are incorporated in their devices to allow...
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Company: American Dental Technologies Inc.Date: 4/18/02 Product: Dental device systems, including PulseMaster 600-IQ and DioLase ST Dental Laser System, PowerPAC High Speed Curing Light System, KCP 5 and 1000 Air Abrasive Kinetic Cavity Preparation System and Ultracam Intraoral Camera System Failure to maintain adequate device master records [21 CFR 820.181] [FDA- 483 Item 5]. For...
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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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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
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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.

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