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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...
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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...
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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...
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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...
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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...
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/docs/MurrayPart11PresentationFoodSafetySummitMarch2003.PDF
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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,...
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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...
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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...
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http://www.ispe.org/page.ww?name=Welcome+to+the+ISPE+GAMP+COP§ion=GAMP+COP
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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...
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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...
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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...
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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...
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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...
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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,...
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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,...
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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 Paper
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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....
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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...
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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...
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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,...
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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,...
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Company: Mediware Information Systems, IncDate of Enforcement Report: 12/18/02 Class: III PRODUCT Hemacare Blood Bank Data Management System, Recall # B-0301-3 REASON Blood bank computer software, which had a defect that could cause antigen test results to be associated with the wrong unit or sample, was distributed. CODE Version 5.2b(b). RECALLING FIRM/MANUFACTURER Mediware Information Systems,...
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Company: Eastern Medical Equipment Distributors Inc.Product: Oxygen USP and Oxygen Analyzer Date: 12/17/02 Failure to routinely calibrate mechanical and electronic equipment used in the transfilling of Oxygen USP or keep records of calibration according to a written program designed to assure proper performance as required by 21 CFR 211.68. For example, there was no documentation...
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Company: Eastern Medical Equipment Distributors Inc.Product: Oxygen USP and Oxygen Analyzer Date: 12/17/2002 Failure to routinely calibrate mechanical and electronic equipment used in the transfilling of Oxygen USP or keep records of calibration according to a written program designed to assure proper performance as required by 21 CFR 211.68. For example, there was no documentation...
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Company: Hamilton CompanyDate of Enforcement Report: 11/13/02 Class: II PRODUCT a) Hamilton Brand Sunrise Software – for the Microlab AT series Instruments; b) Hamilton Brand Sunplus Software – for the Microlab AT Plus and AT Plus 2 series Instruments; Recall # B-0115-3. REASON Automated pipette software, which had a glitch or defect, was distributed. CODE...
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On Nov 12, 2002 FDA released its 5th draft Part 11 guidance “Electronic Copies of Electronic Records”. The date in the document itself is August 2002. This draft is at the link provided. It addressed content, format, and integrity requirements for provision of records in electronic form to FDA.It: – allows that electronic copies do...
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Company: UPC Medical Supplies Inc.Product: Sacred Crane TDP Lamp, QL-Wide Band Spectrum Apparatus and other products Date: 11/01/2002 Claims for the Stimplus II Acupoint Locator & Stimulation device include that it “locate[s] acupoints and then stimulate away the pain electronically at the touch of a button without needles. Acupoints are detected with sound and light…Stimplus...
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Company:Beckman Coulter, IncDate of Enforcement Report: 11/6/02 Class: II PRODUCT Synchron LX 20, Part # 466101; Synchron LX 20 Pro, Part # 466200. Recall # Z-0150-3. REASON Low results on the cartridge chemistry assays, syringe valve seat issue. CODE All units with software version 2.1 are affected. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by...
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Company: UPC Medical Supplies Inc…Product: Sacred Crane TDP Lamp, QL-Wide Band Spectrum Apparatus and other products Date: 11/1/2002 Claims for the Stimplus II Acupoint Locator & Stimulation device include that it “locate[s] acupoints and then stimulate away the pain electronically at the touch of a button without needles. Acupoints are detected with sound and light…Stimplus...
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Company: Beckman Coulter, Inc.Date of Enforcement Report: 10/30/02 Class: III PRODUCT Access 2 Immunoassay Systems — Systems Software Versions 1.0; 1.1; 1.2; and 1.3.1. Recall # Z-0124-3. REASON Erroneous result flags can result on printed reports and screen displays in rare circumstances. CODE Product Name: Access 2 Software Part Number: 973074 Lot Number Software Version...
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Company: Heimann Systems CorporationProduct: Cabinet x-ray system Date: 10/30/2002 21 CFR 1020.40(c)(10) requires that x-ray systems designed for security screening of carried possessions in public facilities shall be provided with means to insure operator presence at the control area in a position which permits surveillance of the ports during generation of x-radiation. We observed that...
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Company: Siemens Medical Systems, IncDate of Enforcement Report: 10/23/02 Class: III PRODUCT Somatom Sensation 16 systems. Software upgrade from Somaris/5 VA50A to VA50B. Recall # Z-0109-3. REASON Scans may be aborted if scans are started manually. CODE Model Number 7393114. Four serial numbers 50012, 50022, 50025, 50029. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc.,...
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/docs/UCIFDAJohnMurray-CDRHSoftwareMEssage101902.PPT
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Company: Unico Holdings Inc.Product: Over-the-counter drug products Date: 10/18/02 In answer to observations made about not performing specific gravity testing as required by the covering monograph, your response states your belief that under certain circumstances not every analytical procedure listed in an article’s monograph needs to be performed, but offers no documentation or historical data...
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Company: Roche Diagnostics CorpDate of Enforcement Report: 10/16/02 Class: II PRODUCT Roche brand Elecsys 2010 clinical chemistry analyzers. Recall # Z-0005-3. REASON Possibile incorrect breast cancer marker results. CODE Serial numbers 1058-11, 1164-70 and 0806-10. (All analyzers with software version 06-01.) RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone on August 8,...
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Company: Abbott Laboratories Inc.Product: Drug products Date: 10/15/2002 Failure to assure that automated equipment will perform a function satisfactorily during the manufacturing process for your drug products [21 CFR 211.68]. For example, The _____ process control computer monitoring system that is used to monitor various production and processing operations (e.g., operation conditions, equipment and component...
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