By

Amy Sellers
National Biomedical Computer System, Versions 1.1 to 1.3.2. Recall #B-861-9. REASON Y2K defect in the computer software incorrectly calculates the end date of a temporary deferral to be 1900 instead of 2000, and removes the deferral from the database. CODE Software versions 1.1 to 1.3.2. MANUFACTURER American Red Cross Blood Services, Arlington, Virginia. RECALLED BY...
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Four Recalls of Picker International Nuclear Cameras and imaging systems12/15/98 Prism XPVT 63 units. Unexpected camera movement which requires the operator to power down and reboot with delay in diagnosis. Z-643/650-9 11/18/98 Model 3000 325 units. Unintended motion of gantry during setup. Z-641/642-9 11/17/98 ModelFX AND fx 800 WITH VERSION 8.3.11 software. 70 units. Software...
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Knoll Pharmaceutical 12/14/98 Your firm’s equipment qualifications for the Amsco SG-116 autoclave and the computer control system for the 60″ film coating pan were inadequate. SoftwareCPR keywords: software validation, CDER, Drugs, Pharma
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12/10/98 Datalink Management System Software Versions 4.1-4.2 Beckman Coulter 248 units. The devices may allow the test results from an associated clinical instrument to be placed under an incorrect sample ID. Z-829-9
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Soft Computer Consultants 12/4/98 Blood Bank Computer SoftwareDESIGN CONTROLS 1) Failure to establish and maintain plans that describe or reference the design and development activities, and define responsibility for implementation including the plans that describe the interfaces with different groups that provide input to the design and development process [21 CFR 820.30(b)]. 2) Failure to...
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PRODUCTVersion 6A and prior versions of software for Marquette Coherent Digital Telemetry (CDT) LAN Monitoring Systems, a patient monitoring system designed to collect and transmit ECG and other physiological data from ambulatory patients, without the patient being physically connected to a display device. Recall #Z-774-0.
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Ultramedic Ltd. 11/25/98 Infusion Pump Analyzers 6. Failure to have an established protocol to validate computer software for its intended use 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, there is no validation protocol for the validation study...
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11/24/98 HMT Medical Technologies Switzerland. Lithotripsy instruments Software versions 3.0 and 1.2. 17 units. Software upgrade yielding error messages and complete lock-up of instruments. Z-680/681
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North American Science Assoc 11/24/98 Contract Testing Laboratory Failure to maintain adequate controls over computers and related systems to assure that changes in the master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)]. For example: (1) there is no current listing of individuals who have access to...
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North American Science Contract Test Laboratory 11/24/98 Failure to maintain adequate controls over computers and related systems to assure that changes in the master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)]. For example: (1) there is no current listing of individuals who have access to the...
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11/2/98 ACS Centaur Automated Chemiluminescence System 244 units with Software Version 1.2 The device may go into premature ready state with bleach still remaining in the analyzeer lines due to a software error. Z-499-9.
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Allergy Laboratories 8/14/98 8. There are no controls for computer generated labeling used for product inserts. It was noted during the inspection that finished HealthTest HIV 1 + 2 and HBsAg test kits were relabeled from “For in vitro use only” to “For Research Use Only”. SoftwareCPR keywords: software validation, CDRH, devices
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ICS Medical 10/29/98 Diagnostic opthalmic devices 1. Failure to develop, monitor, and control the software development processes to ensure that the software used in _____ conforms to its original design or any approved changes. 2. Failure to review the software development process to identify actions needed to prevent the recurrence of software nonconformances. 3. Failure...
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Villa Sistemi Medicali, S.p.A. 9/30/98 Dental x-ray systems Failure to maintain Device Master Records (DMR) that includes or refers to the location of: device specifications including component specifications, software specifications; production process specifications; quality assurance procedures; and labeling specifications as required by 21 CFR 820.181(a)(b)(c) and (d). For example, the firm has no Device Master...
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Software for the Abbott AxSYM System, a fully automated immunoanalyzer. Recall #Z-331-9. REASON Extra assay results from a previous run can appear with new sample results, as well as error messages, due to software defect in the internal result database management. CODE All software versions below 3.03. MANUFACTURER Abbott Laboratories, Irving, Texas. RECALLED BY Abbott...
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Review of the _____ which consisted of the software and hardware components necessary to _____ DHRs and maintain them as electronic records, revealed the following:. Changes to processes were not always reviewed and evaluated or revalidated, where appropriate, and documented [21 CFR 820.75(c)], in that the software validation dated _____ was completed for software _____...
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9/4/98 Nera Electronics/Baxter Healthcare Flo Gard 8200 Volumetric Infusion Pump: Class II 13 units. Board assemblies had the wrong software version installed on them. The boards have version 2.09 instead of version 2.13. Recall #=-Z-777-8.
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10/1/98 Class II Quinton Q-Cath Hemodynamic Analysis System 81 units. Units with version 4.5 software. Device has potential to display previous patient’s blood pressure. Z-855/859-9
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GE Advantx Vascular Imaging Systems, angiographic X-ray systems: a) GE Advantx Vascular Imaging Systems (DX and DLX) with Stenosis Analysis Software and; b) Cardiac Review Stations (CRS) with Quantitative Analysis Software. Safety Alert #N-002/003-9. REASON When procedures in the Operator Manual for stenosis sizing are not followed each time a time measurement is taken, serious...
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Blood Bank Control Systems. Recall #B-020-0. REASON Computer software contains programming errors that could potentially result in the release of a unit that has not been tested for antibodies. CODE Software versions 4.0 and greater. MANUFACTURER Blood Bank Computer Systems, Kent, Washington. RECALLED BY Manufacturer, by letter dated September 1, 1998. Firm-initiated field correction complete....
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Bernafon-MAICO Inc. 5/06/97 “Computer Validation The inspection found that the xxxx Computer System, used to add bulk quantities of solvents to the manufacturing processes (from a tank farm) for Ticlopidine and Bromocryptine Mesylate drug substances has not been validated (FDA-483 Item #16). The response to FDA-483 Item #16 is inadequate. Your firm’s commitment is to...
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Failure to validate and document significant manufacturing processes and quality assurance tests to assure specific requirements are met, e.g., robot and manual welding processes, and software used to program the chip in the control device of the automatic air mattress. Your firm’s response dated July 30, 1998 and signed by Edward A. Kroll, Director, TQM...
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Sabratek Corp. 8/19/98 Infusion pumps 1. Failure to identify the actions needed to correct and prevent recurrence of non-conforming product. For example, it was determined that the _____ had a software problem which prevented the infusion rate from exceeding the bolus rate while operating in the “PCA” mode. While the software has been revised, the...
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Allergy Laboratories 8/14/98 4. Failure to routinely calibrate, inspect, or check for accuracy and to exercise appropriate controls for automatic, mechanical, or electronic equipment or other types of equipment, including computers, used in the manufacture, processing, packaging, and holding of a drug product according to a written program designed so as to assure performance [21...
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8/12/98 Class II PRODUCT Model No. 250 NeuroCybernetic Prosthesis Programming (NCP) Software, Version 5.0 for use only with the Model No. 100 NCP Pulse Generator and Model No. 200 NCP Programming Wand, an implanted autonomic nerve stimulator implanted for epilepsy. Recall #Z-492-0. REASON The software contains a flaw that reports an inaccurate amount of remaining...
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8/10/98 ACS Centaur Automated Chemiluminescence System 29 units with Software Version 1.0-1.2 The test results will be innacurate if the user changes the reporting units and/or slope and intercept for a test. Z-490-9.
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7/20/98 Hewlett Packard Image Point Ultrasound System Model 2410A used in ultrasound imaging to determine stenosis of the sarotid artery. Software Revisions A.0.0 A.0.1, and A.0.1.2. Class II 441 units. Software overestimates peak blood velocity by 15-25% in some Doppler examinations with the Model 2135A transducer. Recall #=Z-160-8.
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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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.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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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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