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Imaging Sciences International Inc. 7/21/98 CommCat IS-2000 Imaging System dental tomographic and panoramic X-ray machine c) Repair requests beyond the one-year warranty period are not reviewed to determine whether they are complaints, nor is information obtained by the software phone service documented and reviewed for potential complaints.
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Multidata Systems Intl. Corp. 7/16/98 Decision Support Systems (DSS) for Radiation Support device 1. Failure of management with executive responsibility to appoint a member of management to establish authority over and responsibility for (a) ensuring that quality system requirements are effectively established and effectively maintained, and (b) reporting on the performance of the quality system...
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Failure to investigate adverse device effects;failure to install password clearance on computer You failed to investigate the failure of the _____ when operating in MS Access. The system locks up at random and it is unknown whether the software which controls the _____ during _____ which operates off of MS Excel, could be similarly affected....
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Hil-rom 6/25/98 Isolette C2000 Infant Incubators Failure to assure that all inspection and testing equipment is suitable for its intended purposes and is capable of producing valid results. The inspection revealed that the _____ automated simulator test has not been updated to keep current with hardware and software changes made to the C2000 device. (FDA...
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6/25/98 Medtronic 9790C Programmers for Kappa 400 Pacemakekers Model 9952A software: Class II 133 units. Bench testing identified a software anomaly that could result in the delivery of an unitended pacing mode or pacing interval. Recall #=Z-715-8
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6/24/98 Beckman/Coulter Access Immunochemistry Set 81500 Software versions 3.22 and 3.23: Class II 1296 units. Sofware anomaly in these versions may allow test results to be posted to a different patient sample number. Recall #=Z-786/787-8.
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m. concerning the _____ software, used for the handling, storage, and distribution of product…Your response states that the _____ software will be validated. Please note that the establishment of an adequate validation protocol, including system specifications and criteria for demonstrating that the software will meet the requirements, is necessary in order to conduct adequate validation.
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6/17/98 Lifescan Surestep Blood Glucose Monitoring System (Meter of home use) Changed to Class I 727,004 units The meters may give an Er 1 (Error 1)message if a patient’s blood glucose is 500 mg/dL or greater.
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Resuscitaire Radiant Warmer, Infant Radiant Warmer: a) Resuscitaire Radiant Warmer, Model RW81; b) Resuscitaire Radiant Warmer, Model RW82; c) Resuscitaire Radiant Warmer, Model RW82VHA; d) Resuscitaire Radiant Warmer, Model WMRW82; e) Resuscitaire Radiant Warmer, Model WBR 81; f) Resuscitaire Radiant Warmer, Model WBR82. Recall #Z-292/297-9. REASON The device fails to control heater power due to...
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/Docs/CBERnew510kparadigmslides4perpage.pdf
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.Select Brand Antacid Peppermint Tablets, 75’s, Lot #7026, manufactured on March 1997, was placed “On Hold”, but was not physically labeled as such, nor did the computerized inventory system indicate this status. Accucal Calcium Antacid Peppermint Tablets, 150’s, Lot #7075 was marked “Rejected” as stored in the warehouse, but this status was not indicated in...
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CIBA Corning ACS 180 Plus Analyzers, used for numerous assays. Recall #Z-359-9. REASON A software error for Troponin I analysis caused erroneous results. CODE All ACS 180 Plus Analyzers with test definition AL software version. MANUFACTURER Chiron Diagnostics Corporation, Oberlin, Ohio. RECALLED BY Manufacturer, by letter/technical bulletin on June 9, 1998. Firm-initiated field correction complete....
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7. You have failed to establish appropriate procedures to assure that computerized processing control systems and data storage systems used in the production and quality systems at Ansell, Inc. are secured and managed to assure the integrity of processes and data that could effect the conformance of the condoms to established specifications. Examples of such...
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Venturi Ventilator, provides a software that continuously adaptsto the patient’s changing breathing demands and assures ventilation at the lowest pressure. Recall #Z-803-9. REASON Software error may cause ventilator to deliver more than set tidal volume. CODE Venturi Ventilator with Software Revision C. Serial #970222. MANUFACTURER Cardiopulmonary Corporation, Milford, Connecticut. RECALLED BY Manufacturer, by letter on...
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Lumisys 5/12/98 MammoWorks” an interactive database designed for mammography practices and teleradiology devices. 1. Failure to develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications [21 CFR 820.70]. For example, your firm does not have sufficient evidence which provides a high degree of assurance that your production process...
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DeRoyal Cientifca Esophageal Stethoscopes 5/1/98 “1. 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). This would also be a violation of the GMP Regulation, 21 CFR...
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Failure to establish adequate written-recall procedures and to validate the computer software programs designed to facilitate recall of distributed drug products.
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Information Management System for Mammography Practices. Recall #Z-187-9. REASON The software was manufactured with methods that resulted in defective information being provided to the physician, and therefore, the patients with positive mammograms may not follow-up with a biopsy exam. CODE All copies of Mammoworks Version 2.6. MANUFACTURER Lumisys, Inc., (formerly Compurad), Tucson, Arizona. RECALLED BY...
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Bioresearch 3/31/98 TMJ diagnosois software Your firm failed to obtain a new 510(k) or pre-market approval after making significant changes to the BioPAK System. Analysis software, i.e., “The Interpreter,” was added to the system to aid in the diagnosis of temporomandibular joint disorders. In addition, your firm is promoting an indication for use (“implants”) that...
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Hitachi 3/30/98 In vitro diagnostic analyzers 1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a) (4). This would be a violation of the 1978 Good Manufacturing Practices Regulation, 21 CFR 820.162, inadequate failure investigation. For example, software release versions were not documented as required or...
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.Controls on your laboratory computer system software _____ allow saved chromatograms to be re-integrated without designation as a saved file. The saved chromatograms that are re-integrated then cannot be restored as original data. SoftwareCPR Keywords: Part 11
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ACS:Centaur Automated Chemiluminescence System, used to conduct various laboratory diagnostictests. Recall #Z-363-9. REASON Software errors for V1.0 which could lead to erroneous test results. CODE All lot numbers for the ACS Centaur. MANUFACTURER Chiron Diagnostics Corporation, Oberlin, Ohio. RECALLED BY Manufacturer, by fax dated March 25, 1998. Firm-initiated field correction complete. DISTRIBUTION Germany and Italy....
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3/17/98 Recon Rx neurological biofeedback monitoring1762 units Rx unit were not functioning correctly. Obsolete version 3.01 software had been installed in the units.
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… Failure to ensure that automatic, mechanical, and electronic equipment, including computer(s) are inspected or checked according to a written program designed to assure proper performance [21 CFR 211.68]. For example, your computer software used for tracking raw material, finished product quarantine/release, and archiving master formulas has not been validated…. SoftwareCPR Keywords: Drug, Pharma
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Scottcare 2/25/98 TeleRehab II Cardiopulmonary Monitoring System Failure to maintain a complete Device History Record (DHR) in that it does not contain updates to software or their location, or document rework and evaluation of non-conforming finished devices or part.
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Venturi Ventilator, used to provide a software that continouslyadapts to the patient’s changing breathing demands and assures ventilation at the lowest pressure. The display monitor provides pertient patient parameters and waveforms. Recall #Z-802-9. REASON Display monitor may go blank due to faulty inverter. CODE Serial numbers: 970192, 970190, 970154, 970164, 970169, 970172, 970138, 970161, 970163,...
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Nikkiso Co. Ltd. 1/27/98 Hemodialyzers 2. Failure to validate computer software for its intended use according to an established protocol when software is used as part of production or the quality system, as required by 21 CFR 820.75(j). For example, the software used to perform _____ has not been validated. This software is part of...
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Witt Biomedical Corp. 1/23/98 Cardiac catherization monitoring system Failure to establish and maintain adequate procedures for changes to a specification, method, process, or procedure, e.g., software installation procedures are being changed without using an approved process pursuant to established procedures;
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Mennen Medical Ltd. 1/21/98 Patient Monitors c. The approval page for the Horizon 9000WS Cathlab’s software located in the document control department contained the signature of the originator of the document, but it lacked an approval signature. This approval page was different from the approval page for the same software located in the production department....
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Failure to document approval of all documents established to meet the requirements of part 820, including the date and signature of the individual(s) approving the document, as required by 21 CFR 820.40(a). For example, the device master record was not signed or dated to indicate approval, and the master and working copies of Software for...
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No evidence of validation of computer system or software; use of unrecognized testing methods for testing and release of finished products; and no review and approval by the Quality Control Unit of Oxygen USP and Nitrogen NF. 1. No documented evidence of the validation for the computer system or associated software that is responsible for...
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Failure to validate the finished device testing software for the ProNeb and Duraneb 2000 compressors and complaint handling software according to established protocols; failure to establish written procedures for monitoring and control of process parameters; failure to establish written procedures and to develop specifications for the contract manufacturer; and failure to establish final acceptance procedures....
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b. Changes made to the software program for the _____ have not been formally reviewed and approved by designated representatives of the firm…..Your response is not adequate because it does not include documentation showing formal review and approval of the software program changes. a. A user manual (or SOP) is not available for the _____...
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3) There are insufficient controls in place to ensure the integrity of calculated data generated by the _____ software in the Quality Control Laboratory, in that:.
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CIBA Corning ACS:180 SE Analyzer, used to conduct various laboratory diagnostic tests. Recall#Z-369-9. REASON Software error causes 16 different assays to not calculate SI units correctly. CODE All lot numbers for ACS 180 SE Analyzers. MANUFACTURER Chiron Diagnostics Corporation, Oberlin, Ohio. RECALLED BY Manufacturer, by fax on November 25, 1997. Firm-initiated field correction complete. DISTRIBUTION...
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