The Center for Devices and Radiological Health (CDRH), Office of Compliance, Division of Enforcement I, Diagnostic Devices Branch has reviewed the January/February 1999 Establishment Inspection Report of your firm, and the Form FDA 483 dated February 5, 1991, that was issued to you at the close of the FDA inspection. They also reviewed your product...Read More

3/29/99 Digisonics Class II OBLink software releases prior to 9.0 39 units. Y2K sofvtware error may produce an incorrect estimated delivery date (EDD). Z-1056-9.Read More

Radionics 22-March-99 Xknife Stereotactic Radiosurgery System 1. Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, that appropriate representatives are included, and that the results of a design review, including identification of the design, the date,...Read More

Abbott 17-March-99 In vitro diagnostic products 2. Failure to document all activities required by 21 CFR 820.100(b) as they relate to corrective and preventive action. For example: a. There is no documentation of the management review and approval of the decision not to send a customer communication to alert Axsym instrument users of a system...Read More

Baxter 3/12/99 Catheters 2. Failure to validate production processes with a high degree of assurance where the results of a process cannot be fully verified by subsequent inspection and test [21CFR 820.75). Specifically, your firm does not have sufficient documented evidence, that the Pulmonary Artery Catheter balloon forming, and the polyethylene (PVC)compounding processes meet their...Read More

“Capability Maturity Mode Implementation and Risks” byTracey Briscoe of Quality Systems and Software (maker of the DOORS requirements management tool).This white paper provides a concise overview of the CMM and some common issues regarding its value, costs, and implementation approach. Quality Systems and Software has a variety of white papers and courses offered on its...Read More

Eagle 3000 Floorloader Steam Sterilizer. Recall #Z-936-9. REASON There is an error in the control system software, which causes the chamber temperatures to exceed the upper limit. CODE Various serial numbers. MANUFACTURER Steris Corporation, Erie Pennsylvania. RECALLED BY Steris Corporation, Mentor, Ohio, by Customer Notifications on March 10, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada,...Read More

Medical Equipment Designs 9-March-99 Diathermy devices Since 1990, you also modified the design of the Meditherm by introducing software to control the device. Major changes in the intended use of the Meditherm and design changes which could significantly affect safety or effectiveness, such as the introduction of software, require a new premarket notification (510(k)) submission...Read More

Urometrics 9-March-99 Penile tumescence monitors 1. Failure to establish and maintain procedures for the identification, documentation, validation, or appropriate verification, review and approval of design changes before their implementation as required by 21 CFR 820.30(i) in that there is no data to show that the NEVA program version 2.2.1 (revised 1/20/99) was validated or verified....Read More

In response to your inquiry concerning the need to maintain manual discard records when the same date is computerized, I can assure you that duplicative, manual records are not required, PROVIDED your computer system(s) are validated to ensure that all necessary data is entered, that the stored data is safely backed-up in the event of...Read More

Philips Medical Sonodiagnost 800, intended for endovaginal biopsy for various gynecologic and obstetric procedures including follicular retrieval, endometrial biopsy, and fluid aspiration of any type in a potentially pregnant patient. Recall #Z-772-9. REASON Software used with Transducer EV7014 incorrectly indicates track of the biopsy needle. CODE All SD800’s with Software versions 2.1. and 2.1.1 used...Read More

3/5/99 Class II Hewlett Packard 145 units. Software used with transducer EV7014 incorrectly indicates track of biospy needle. Z-772-9Read More

Chronimed 3/2/99 Glucose test strips and meters 5. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation as required by 21 CFR 820.30(b). For example, there is no plan for the software validation for Version 104. 6. Failure to ensure that the design input...Read More

All IMMULITE 2000 Automated Immunoassay Analyzers with SoftwareVersion 1.1, a clinical automated immunoassay analyzer intended for in-vitro diagnostic use for detection of analytates in human specimens. Recall #Z-909-9. REASON If the initial counts of the reaction tubes are exactly 10,000 cps, this leads to erroneously low calculated results. CODE All serial numbers in commercial distribution...Read More

Abbott Cell-Dyn 3000 Series Hematology Systems, Cell-Dyn Reticulocyte Reagent, when used in combination with Cell-Dyn 3500 reticulocyte software enables a whole blood specimen to be analyzed for reticulocytes. The Reticulocyte Reagent is intended for in vitro diagnostic use (outside the body). Recall #Z-715-9. REASON These lots may exhibit elevated Reticulocyte results. In some cases, the...Read More

Compex S.A. 2/22/99 Muscle and nerve stimulation devices 2. 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, your firm failed to validate the software...Read More

2/16/99 Class II 128XP Acuson 637 units. Rev 27 software with OB calculations options are affected. Potential error condition related to OB reports printed after diagnosis. Z-787-9Read More

Solar 7000 and Solar 8000 Patient Monitors with Version 5D Software, used to display physiological data from modules which monitor the patient for ECG, blood pressure, cardiac output, respiration, pulseoximetry, etc. Recall #Z-727/728-9. REASON A software deviation can affect the alarm default settings, which may result in incorrect or missed alarm notification. CODE Solar 7000/8000...Read More

Inadequate process validation; failure to validate the test methods used to analyze raw materials and the finished product; failure to institute process qualification for the laboratory instruments used to perform in-process and finished product testing; failure to qualify or validate the firm’s computer software programs; and failure to perform investigations into out-of-specification weight and diameter...Read More

Diehl Inc. Food Processing 2/12/99 The chart recorder and the computer display on the xxxx units did not correspond to the mercury-in-glass (MIG) thermometer. The chart recorder or computer display may show a reading up to 3 degrees F higher than the MIG thermometer. SoftwareCPR keywords: Production software, validation, electronic recordsRead More

10-Feb -99 Precision Therapy International. 190 units. Class II. 3-D Imgcomp Utility User Manual Update. Version 2.72b & 3.07d. A design error may leadto a serious miscalculation of radiation dose. Z-1223-9Read More

2/9/99 Class II Bayer AADVIA120 Hematology System 920 units. The device may give erroneous reslts because of the valve gasket deterioration in the Baso channel check valve, and the software designed will not flag significant discrepancies in the results between the two methodologies at extremely low counts.Z-869/870-9Read More

2/5/99 Class I recall Marquette Electronics ECG, blood pressure, cariac output, respiraion, pulse oximetry Monitors. 607 new units and 97 update kits. A software deviation can affect alarm default settings, which may result in incorrect or missed alarm notification. Z-727/728-9Read More

2/1/99 Abbott Alcyon 300 Analyzer (IVD) Possible mixup of patient results. 631 units. Z-617-9Read More

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...Read More

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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...Read More

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, PharmaRead More

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-829-9Read More

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...Read More

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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.Read More

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...Read More

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-680/681Read More

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...Read More

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...Read More

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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.Read More

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, devicesRead More

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...Read More

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...Read More

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...Read More

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 _____...Read More

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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-855/859-9Read More

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.Read More