Company: Beckman Coulter, Inc.Date of Enforcement Report: 5/28/03 Class: III PRODUCT COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use. Recall # Z-0805-03. REASON Software problem may cause the instrument to skip the probe-wash step before processing different reagents. CODE All existing versions of the software. Serial numbers PrepPlus 0006026440 and above...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 5/21/03 Class: II PRODUCT AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01. Recall #Z-0788-03. REASON Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride. CODE All lots. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX,...Read More

On February 20, 2003, a final security rule 45 CFR Part 142 was issued. A copy is at this link: HIPAA Final Security Rule 2003-02. 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...Read More

A presentation of a proposal for EU software regulation at the ISPRA meeting on Medical Device Software May 13, 2003, is at the link provided. Some of the suggestions are based on FDA guidance documents. ISPRA Meeting on SW This presentation was provided by Poul Schmidt-Andersen of Copenhagen Medical Devices, which is an affiliate of SoftwareCPR....Read More

Company: ConMed Corp. Product: Hyfrecator 2000 and other electrosurgical devices and accessories Date: 05/08/2003 Failure to validate computer software for its intended use according to an established protocol prior to approval and issuance, and document the results of these validation activities, as required by 21 CFR 820.70(i). For example, a software program used to run...Read More

Company: Antelope Valley Healthcare District Product: Blood and blood components Date: 05/01/2003 Specifically, the procedure “Donor Registration and Medical Interview,” which includes instructions for entering deferral information into the computer system based on disqualifying information provided during the donor screening process, does not provide details concerning the documentation of information (such as exposure dates) so...Read More

Company: Siemens Medical SolutionsDate of Enforcement Report: 4/30/03 Class: III PRODUCT ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems. Recall # Z-0727-03. REASON ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions. CODE All Diacam, Multispect...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 4/30/03 Class: III PRODUCT Aeroset Software versions 1.00ER005, catalog number 2-89996-01; and software version 1,00ER005.2, catalog number 2-89996-02. Recall # Z-0725-03. REASON Under certain operating conditions, smart wash feature disables with multiple samples. CODE No codes. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by letter on February 24,...Read More

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Company: Misys Healthcare SystemsDate of Enforcement Report: 4/23/03 Class: III PRODUCT Misys Laboratory_ Blood Bank System computer software (3 versions). Recall # B-0791-3. REASON Blood bank computer software contained a defect that could result in the incomplete displaying of red blood cell antigen and antibody information for a unit of blood. CODE Version numbers 5.2,...Read More

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Company: Misys Healthcare SystemsDate of Enforcement Report: 4/9/03 Class: II PRODUCT Misys Laboratory System Version 5.3. Recall # Z-0670-03. REASON Software anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on February 19, 2003. Firm...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 4/9/03 Class: II PRODUCT Misys Laboratory, Calculator Data processing Module for Clinical Use. Recall # Z-0678-03. REASON Software anomally. Graphical display omits results containing a less than () or percent (%) symbol. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ., by fax on January 17, 2003....Read More

Company:Beckman Coulter, IncDate of Enforcement Report: 4/9/03 Class: III PRODUCT LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645. Recall # Z-0669-03. CODE REASON Incorrect Hemoglobin result can be reported at software version 2A and higher. All instruments with version 2A or higher. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by telephone and letters...Read More

Company: Cti Pet Systems, IncDate of Enforcement Report: 4/9/03 Class: II PRODUCT ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+,ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT...Read More

http://www.fda.gov/cber/blood/bldreginstr.htmRead More

A white paper at the link provided gives an overview of the status of European Union medical device software regulation and provides suggestions on software validation. Some of the suggestions are based on FDA guidance documents. CMD Swartikel This paper was provided by Poul Schmidt-Andersen of Copenhagen Medical Devices which is an affiliate of SoftwareCPR.Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 3/26/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0614-03. CODE Versions 5.2, 5.23 and 5.3. REASON Software anomaly. Rejecting the selected Autofiling status may result in the change being accepted rather than rejected. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 3/26/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0626-03. REASON Software anomaly. Patient results may be filed in the incorrect patient file. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm initiated recall is ongoing. VOLUME...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 3/26/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0647-03. REASON Software anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface. CODE Version 5.3 with Reference Laboratory Interface. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Tucson, AZ, by facsimile on October 18, 2002. Firm...Read More

Company: Varian Medical Systems, IncDate of Enforcement Report: 3/26/03 Class: II PRODUCT VARiS 1.4G and Vision/Soma Vision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x. Recall # Z-0633*03. REASON The product has a software problem. This could result in a treatment without a motorized wedge where one had...Read More

Company: Advanced Radiation Measurements Inc.Product: Radiation beam scanners Date: 3/25/03 Your firm failed to validate processes whose results cannot be fully verified by subsequent inspection and test according to established procedures as required by 21 CFR 820.75. Structural testing conducted as part of your firm’s software validation, and software validation of the Scan Test used...Read More

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Company: Misys Healthcare Systems, Inc.Date of Enforcement Report: 3/12/03 Class: II PRODUCT Misys Blood Bank System. Recall # B-0581-3. REASON Defect in the design of blood bank software programs could result in the release of unsuitable blood product. CODE Version 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc. (formerly Sunquest Information Systems), Tucson,...Read More

Company: Baxter Healthcare, Corp..Date of Enforcement Report: 3/5/03 Class: III PRODUCT a) HomeChoice Automated Peritoneal Dialysis Systems; Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R. Recall # Z-0564-03; b) HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R. Recall # Z-0565-03. REASON Potential for low ultrafiltrate volumes...Read More

Company: Innovative Products Unlimited Inc.Product: Medical Device products including gurneys Date: 3/4/03 No procedures to control labeling activities, as required by 21 CFR 820.120. For example, while you maintain master labels for your gurney models, these master labels lack signatures and dates to document that they have been reviewed and approved, and there are no...Read More

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http://www.ispe.org/page.ww?name=Welcome+to+the+ISPE+GAMP+COP§ion=GAMP+COPRead More

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FDA issued a formal federal register notice announcing a new draft guidance for Part 11 titled “Part 11, Electronic Records, Electronic Signatures Scope and Application”. This notice also: officially withdraws not only all earlier draft Part 11 guidance documents but it also withdraws the Part Compliance Policy guide formally announces FDA’s intent to reexamine its...Read More

Today, FDA issued a new Part 11 guidance draft that reduces the scope and burden of Part 11 significantly.  It essentially suspends enforcement on legacy systems existing prior to the rule’s effective date in 1997 and eliminates: enforcement related to audit trails, electronic copies, and maintenance of electronic records by focusing on meeting the intent...Read More

ADVAMED and NEMA sent a letter to Dr. Feigal (Director of FDA’s Device Center) raising concerns about Part 11 based on a recent meeting with FDA. They are objecting to the return of Part 11 responsibility to the drug center with no formal device center involvement and the potential that the drug center will issue...Read More

Company: MAK-SYSTEM S.A. International GroupProduct: Progesa Soundex file module Date: 02/06/2003 All users are not notified of existing problems or fixes until a user encounters the problem. Software corrections are only provided to the user that discovered and reported the problem and not to other users of the computer system/software. For example There were no...Read More

Although the HIPAA Privacy Rule directly effects “Covered Entities” medical device and pharmaceutical manufacturers may be involved in inadvertent release of private patient information and must deal with requirements from their customers that are Covered Entities. It was reported that: Eli Lilly, already has settled with eight states and the Federal Trade Commission for $160,000...Read More

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Company: Merits Health Products Co. Ltd. Product: Powered wheelchairs, electric scooters and oxygen concentrators Date: 02/04/2003 Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example,...Read More

/Docs/SCPRed/SoftwareCPR-Newsletter0103.PDFRead More

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http://www.fda.gov/cber/gdlns/qsrpma.pdfRead More

Company: Misys Healthcare Systems, Inc.Date of Enforcement Report: 1/29/03 Class: II PRODUCT Misys Blood Bank System. Recall # B-0455-3. CODE Version 5.2, 5.23, and 5.3. REASON Defect in the design of blood bank software programs could result in the release of unsuitable blood product. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc. (formerly Sunquest Information Systems), Tucson,...Read More

ADVAMED provided a white paper to FDA as part of the Part 11 Industry Coalition. This paper proposes that health and safety risk be used to properly interpret and apply Part 11 and that this approach would resolve some of industry’s issues rather than an approach focused on fraud. ADVAMED BLiebler Part11 Risk PaperRead More

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Company: Lexicor Medical Technology Inc.Product: DataLex Web portal Date: 1/16/03 We are writing to you because on July 3 through 17, 2002, an investigator from the Food and Drug Administration (FDA) collected information that revealed a serious regulatory problem involving the product known as “DataLex” web portal which is made and marketed by your firm....Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 1/15/2003 Class: III PRODUCT EXPO 32 Software. Recall # Z-0407-3. REASON Software contains errors that might affect Cytometry instruments. CODE Versions 1.0, 1.1B, and 1.2. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letter on May 20, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More

Company: Siemens Medical Solutions USA Inc.Product: Diagnostic x-ray system Date: 1/14/03 You are requested to report the results of your investigation and follow-up action to this office within thirty (30) working days of receipt of this letter. Your response should include the date that the corrective action was completed and copies of service records and/or...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 1/8/2003 Class: II PRODUCT AXIS/IRIX Gamma Camera System, controlled with Odyssey computers, operating with version 8.5 software. Recall # Z-0353-3/Z-0364-3. The systems are controlled with Odyssey computers that are connected to a Prism gantry. Some Odyssey computers operate as stand alone workstations. A Prism XPVTSystem, Tomography, Computed, Emission,...Read More

Company: Baxter Healthcare CorpDate of Enforcement Report: 12/25/02 Class: II PRODUCT HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Made in U.S.A.; Recall # Z-0334-3/Z-0339-3. The following models are affected: a) Baxter HomeChoice Automated PD System, catalog 5C4471, 115 volt; b) Baxter HomeChoice Automated PD System, catalog 5C4474, 220 volt; c) Yume Automated PD System,...Read More

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