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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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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 OfficeRead More

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...Read More

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...Read More

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,...Read More

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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...Read More

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...Read More

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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...Read More

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...Read More

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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,...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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,...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

Company: A-VOX Systems Inc.Date: 4/18/2002 Product: Various oximeter models used for whole blood measurements and disposable cuvettes Failure to maintain procedures to ensure all purchased or otherwise received products and services conform to specified requirements [21 CFR 820.50; see also 820.80]. For example, your firm failed to ensure that the supplier of the main computer...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 4/17/02 Class: II PRODUCT Misys Laboratory (formerly FlexiLab) information system. Recall # Z-0803-2. REASON Software anomaly may allow patient results to be transposed against another patient header or identification. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tuscon, AZ, by notice on March 8, 2002....Read More

Class: III Aeroset Chloestorol Reagent Lot 82099HW00. Firm’s list no. 7D62-01. Manufacturer: Abbott Laboratories, Inc., Sout Pasadena, CA Recalled by: Manufacturer, by letters on April 17, 2002. Firm initiated recall is ongoing Distribution: Nationwide and internatinally; 715 units were distributed Reason: Stability may be compromised over time, product currently OK Recall number: Z-1031-2Read More

Company: Sunquest Information Systems, IncDate of Enforcement Report: 4/10/02 Class: II PRODUCT FlexiLab Laboratory Information System. Recall # Z-0710-2. REASON Date Format Issue–Flexilab Software converts specimen collect and receipt dates to American standard format ‘mm/dd/yyyy’. For sites using the Euro date format this can alter the generation of QA warnings or flags based on collect...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 4/10/02 Class: II PRODUCT All DataCare Systems Software, as follows: 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 environment; Catalog GD9201...Read More

“A Methodology for Safety Case Development” was the result of a research grant. It discusses development of safety cases. Essentially development of justification for the safety of software in a given system/use. While FDA requires risk and software hazard analysis there is significant value, in our opinion (SoftwareCPR), in constructing rationale that demonstrates safety rather...Read More

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Company: Abbott Laboratories, Inc Date of Enforcement Report: 3/24/02 Class: II PRODUCT AEROSET System Software v1.00ER005.2 and v1.0ER005 Catalog Numbers: 2-8996-02 and 2-89996-01. Recall # Z-0594-2/0595-2. REASON System may incorrectly associate sample ID & test requests undercertain conditions of non-bar coded or unreadable bar coded samples. CODE All Codes are affected by this field correction....Read More

Company: Bayer CorporationDate of Enforcement Report: 3/27/02 Class: III PRODUCT Clinitek 100 Software Kit. Recall # Z-0634-2. REASON False negative results when high concentrations of ketone exist. CODE Version 7.00. RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corp., Elkhart, IN, by telephone and fax on January 21, 2002. Manufacturer: Bayer Corporation, Mishawaka, IN. Firm initiated recall is...Read More

Company: Siemens AG Medical EngineeringDate of Enforcement Report: 3/27/02 Class: III PRODUCT a) ACOM.PC Angiographic X-ray System; b) Digital Image Communications System. Recall # Z-0603-2. REASON Software problem in recording heights and weights. CODE Siemens part number: a) ACOM.PC V3.0-4371105 b) Quantcor V4.0-4786898, 5915553, 5915579. Equipment Concerned: Product: Part No. Serial No. LVA V 4.0...Read More

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