By

Amy Sellers
PRODUCTComponents and Distribution Information System (CDIS) Stand Alone Blood Bank Software. Recall #B-1094-0. REASON Blood bank software contains a defect that results in not all products produced from a donation receiving the special donation properties that are applicable to donation. CODE All versions up to and including version 1.1.1. MANUFACTURER Information Data Management, Inc., Rosemont,...
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Failure to establish and maintain procedures for validating the device design to include validation and to perform design validation under defined operating conditions on initial production units, lots, or batches, or their equivalents; and failure to ensure that devices conform to defined user needs and intended uses and to include testing of production units under...
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Failure to develop, conduct, control and monitor production processes; failure to review the associated data and documentation for finished devices prior to release; failure to validate processes adequately; failure to establish and maintain procedures for implementing corrective and preventive action; failure to validate computer software adequately; and five other violations. Failure to validate computer software...
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The computer software your firm uses to determine metals analysis is deficient. It has no security measures to prevent unauthorized access of the software, no audit trails, and data can be copied or changed at will, with no documentation of the copying or changes. Your procedures do not require the documentation of calculation or entry...
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You failed to evaluate suppliers of components and other materials used to assemble the WatchChildTM device. You had not documented your decisions to use the approved vendors on the approved vendor list. While you have a written procedure for supplier certification and recertification, it was not being followed. The type and extent of control to...
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6. Failure to designate an individual to review for adequacy and approve prior to issuance all documents established to meet the requirements of Part 820 as required by 21 CFR 820.40(a). For example: a) There is no requirement for documenting the signature of the individual approving the document. In your firm’s letter of April 6,...
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Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70( i). For example, the firm did not validate software for electronic records and electronic signatures. Your written responses dated Feb. 25, April 3, and April 13,2000, stated that you would formalize the policy regarding electronic...
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.Failure to maintain device master records (DMR’s) for each type of device including or referring to the location of device specifications, including appropriate drawings, composition, formulation, component specifications, and software specifications, as required by 21 CFR 820.181(a) . For example:.
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You have also failed to establish written procedures for all operations being performed by your blood bank. No written procedures are established for registering donors electronically, registering donors manually on your mobile unit, maintaining your donor base and searching for duplicate and/or unsuitable donors on a set schedule, review of donor suitability records to assure...
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PRODUCT Version 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. REASON Due to a software defect, there could be...
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PRODUCT Architect i 2000 System. Recall #Z-906-0. REASON System allows running of samples while the automatic flushing/cleaning occurs. CODE All units, all software versions. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois, by letter on April 25, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide, Puerto Rico, Korea, Mexico, Canada,...
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Limberg Eye Center 4/17/00 Failure to maintain complete and accurate records [21 CFR 812.140(a)]. Information on some of the case report forms (CRFS) did not agree with the computerized subject records and vice versa for those records that were originally captured on the CRF and then transcribed to the computerized source records. Moreover, UCVA readings...
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Harper Hospital Blood Bank 4/13/00 Failure to perform/maintain computer validation [21 CFR 211.68] in that: there was no validation protocol to show how the system was tested and what were the expected outcomes; there was no documentation to identify the operator performing each significant step, date completed, whether expected outcomes were met, and management review;...
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Euclid Systems – contacts 4/12/00 The devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods “used in, or the facilities or controls used in the manufacture, processing, packaging, storage, or distribution of Orthokeratology (itaflurofocon B), toric, and aspheric contact lenses, are not in conformance with the Quality System...
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Exmoor advised in its response that professional auditor training will be provided and that subsequent in-house training will be conducted and documented for key staff with auditing responsibilities. Furthermore, training needs will not only be assessed during appraisal and counseling sessions, but also during Quality Management Review Meetings, external audits, internal audits and corrective actions....
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Electric Mobility – Scooters and power chairs 4/3/00 “…Your firm did not validate your _____ computer system which is used for quality control data, order entry and inventory functions. [21 CFR 820.70(i)” SoftwareCPR keywords: production software validation
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PRODUCT Roche Hitachi 914 Chemistry Analyzer, used for diagnostic testing for routine and specialty chemistry analytes. Recall #Z-613-0. REASON There is a potential for mismatch of sample identification information and results on this version of software. CODE Catalog number 914000. All units with software version 3.0. MANFACTURER/SOFTWARE SITE Roche Diagnostic Corporation, Indianapolis, Indiana. RECALLED BY...
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PRODUCT Roche/Hitachi 917 Disk System Chemistry Analyzer, Catalog #917000. Recall #Z-612-0. REASON There is a potential for mismatch of sample identification information and results on all versions of software. CODE All units/software versions. MANFACTURER/SOFTWARE SITE/SOFTWARE SITE: Hitachi Instruments Division, Ibari-ken, 312 Japan. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter dated March 17, 2000....
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St. Joseph’s Hospital and Medical Center Blood Bank 3/16/00″…6. Inadequate computer security in that employees have access to functions they are not qualified to perform. For example, Technical Assistants (TA) have access to the Blood Order Processing function, Blood Label Check function and Blood Product Testing function, although they are not qualified to perform the...
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PRODUCT a) Precision Link Blood Glucose Data Management System Software Version 2.0 and 2.1; b) Precision Link Plus Data Management Software Version 1.0. The program extracts test results from glucose monitors and converts these results into charts, graphs, and reports. It provides information to monitor diet, exercise, and medication. Recall #Z-913/914-0. REASON Glucose values greater...
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Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example, the _____ used to ____ in _____, has not been validated, to assure it is...
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Thoratec Laboratories 3/10/00″..4. .The implementation of corrective and preventative action (CAPA) procedures at your firm is incomplete in that your procedures do not include reference to the Access electronic database. This database captures information from sources such as complaints and nonconformance reports for use during management reviews. In addition, battery assembly defects, such as loose...
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PRODUCT Fixer Image Scan Editing Utility, Version 3.0, intended to allow the user to remove spurious image slices from a scan. Recall #Z-784-0. REASON Fixer 3.0 may provide inconsistent results if a file is changed and saved twice in the same session. CODE Fixer Software Utility Version 3.0 MANUFACTURER Radionics, Inc., Burlington, Massachusetts. RECALLED BY...
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PRODUCT MINICAP XP Workstations, using Baseline 8.5 software, for Computed Tomography SPECT studies with gamma cameras. Recall #Z-515-0. REASON During 360 degree SPECT, the resulting image will appear flipped left to right. CODE All Marconi MINICAP XP workstations using the Baseline 8.5 software. MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio. RECALLED BY Manufacturer, by...
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PRODUCT SoftBank LIS or Softbank Laboratory Information System. Recall #B-692-0. REASON There is no way of assuring that ADT-Interface transactions will always include correct patient data. CODE All versions installed in computer systems. MANFACTURER Soft Computer Consultants, Palm Harbor, Florida. RECALLED BY Manufacturer, by letters dated February 28, 2000, followed by visit. Firm-initiated field correction...
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All Architect I System Processing Modules with Software Versions1.0 and 1.01. Recall #Z-910-9. REASON The device may report incorrect results for diluted samples; and/or when used with the Laboratory Information System or Host Information Systems, the system may incorrectly associate test results with patient ID or incorrectly associate control results with patient records. CODE List...
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2/24/00 Class II PRODUCT Aeroset Assay Disks, V3.0 Conventional Units, used as a software diskette to upgrade the Aeroset System, which is a clinical chemistry analyzer, used for in-vitro diagnostic tests. Recall #Z-488-0. REASON The disks are improperly duplicated and contain software that will install System International (SI) units, rather than conventional units as labeled....
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PRODUCT Magnetom 42 SP Magnetic Resonance Imaging System with Software Version Number 2A2.7B. Computer aided medical device generates magnetic field resulting in a digital image of the body: a) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 89 69 131 (SP-A); b) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 87-29-485 (SP). Recall...
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2/21/00 Class II PRODUCT Aeroset Analyzer, used for in-vitro diagnostic tests. Recall #Z-489-0. REASON Under certain washing conditions, software error causes erratic urine creatinine results. CODE All Codes. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Manufacturer, by letter dated February 21, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 176 analyzers were...
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REASON Failure to correctly re-calculate drug dosage using saved Drug Dosage Data. PRODUCT Infinity Modular Bedside Monitors, Models SC7000, SC8000, SC9000, SC9000XL, intended for adult, pediatric, and neonatal monitoring of clinical environment. Recall #Z-399/401-0. CODE Infinity Modular Monitors: SC7000, SC8000, SC9000, SC9000XL with software versions VEO, VEO.1 or VEO.2 MANUFACTURER Siemens Medical Systems, Inc., Danvers,...
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Individual Monitoring Systems -Electroencephalogry 2/11/00 “…Failure to validate computer software for its intended use. For example, your firm has not validated the software used to perform sensitivity calibration of the ActiTrac device. “ SoftwareCPR keywords: production software validation.
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http://www.fda.gov/foi/warning_letters/m3401n.pdf
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REASON Potential for incorrect Pediatric Reports–A software problem. PRODUCT a) 2-way MainFrame Interface Software Version 22.20; b) Pediatric Therapy Guide Version 4.10. Recall #Z-405/406-0. CODE Part Numbers: 9800-2666 and 9800-0630; Catalog Numbers: B1018-15 and B1011-30. MANUFACTURER Dade Microscan Inc., West Sacramento, California. RECALLED BY Manufacturer, by letter on February 4, 2000. Firm-initiated field correction ongoing....
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REASON Due to a software anomaly, the device acquires data from a slice thicker than intended, and may not be at isocenter. PRODUCT Chemical-Shift Imaging (CSI) Spectroscopy, Model 90LNI. Recall #Z-412-0. CODE Serial Numbers: AF212E, BA109P, BA218P, BA103P, AF165E, AF157EU, BA183P, BA118P, BA182P, BA164D, BA178P, BA114P, BA225P, BA187P, AF113EU, BB104P, BA110P, BA131D, and BA192D. MANUFACTURER...
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Compnay: SOL PharmaceuticalsProduct: Active pharmaceutical ingredients Poduct Category: Human Drugs Date: 1/21/200 In addition, our investigative team found it impossible to trace computer generated …because they were not date stamped.
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1/13/00 Class II PRODUCT Alycon Analyzers, automated chemistry analyzers for in-vitro diagnostic use: a) Alycon Analyzer 300; b) Alycon Analyzer 300i. Recall #Z- 462/463-0. REASON Software program errors cause incorrect association between patient and the patient results. CODE All codes. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Manufacturer, by letter dated January 13, 2000....
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1/8/00 Class III recall PRODUCT Software for Pulmonary Function Testing System: a) BreezePF v3.8 Software, Catalog No. 147536-003; b) BreezePF v3.8A Software, Catalog No. 147570-003. Recall #Z-450/451-0. REASON An anomaly has been discovered in the software that can cause confusion on the selection of which FEV1/FVC ratio is selected for diagnostic reporting. The problem only...
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REASON Software error in Vitros ECi Immunodignostic system. PRODUCT Vitros Immunodiagnostic System, a random access immunodiagnostic analyzer for quantitative and qualitative determination of analytes in human specimens. Recall #Z-360-0. CODE Catalog #8633893, Serial #30000054-30001120. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York. RECALLED BY Manufacturer, by letters dated December 28, 1999, and January 13, 2000, and...
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Diasorin, Saluggia Italy 23-Dec-99 production/QC software validation for reagents”8. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use [21 CFR 820.70(g)] in that the Gamma Counter Data Transfer Validation, dated March 31. 1999. did not...
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REASON Software may incorrectly link previous assay results to a different patient ID. PRODUCT Chiron Diagnostics Automated Chemiluminescence System, Model ADVIA:CENTAUR for the quantitative determination of various in vitro diagnostic assays using direct chemiluminescent technology. Recall #Z-358/359-0. CODE Catalog Numbers: 114564, 572561, 572562, 572563, 572564, and 572566. All ADVIA:Centaur Immunoassay Analyzers with software versions 2.01...
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PRODUCT AcQ Plan, 3-D Radiation Therapy Treatment Planning System (software), a software option for the Computed Tomography (CT) Scanners. Recall #Z-300-0. REASON Software anomaly causes the isocenter shift to be labeled incorrectly. CODE All units using the AcQPlan Therapy Planning software version 4.04 are affected. MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio. RECALLED BY...
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7. Failure to maintain complete and adequate written SOPS that reflect current bloodbank operations as requiredby21 CFR 606.100(b) and 606.60. For example, with respect to the computer system in use, there were no SOPS available for security procedures for unauthorized access, review of the system and correction of errors, and control of changes in hardware...
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3d) Standard operating procedure Routine Release of Crossmatched Blood and Blood Products has not been updated to include computter operations utilizing xxx Blood Bank and Blood Donor Computer System versionyyyy. Specifically, the procedure does not include what type of second verification of information entered into the computer should be performed when blood products are released...
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PRODUCT Mini-Med MMT-508 Insulin Pump, indicated for the continuous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Recall #Z-288-0. REASON The pump’s software has an error in which the current basal rate profile indicated on the pump display, was a rate programmed for earlier in...
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Failure to validate the EtO sterilization process for ATI plasma exchange tubing setsand off-the-shelf software for compiling clinical trial data. Also there are no procedures established and maintained for monitoring and controlling the process parameters for the ATI plasma exchange tubing sets to ensure that specified requirements are met as required by 21 CFR 820.75....
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100 copies. Pato Brachytherapy Treatment Planning System Version 13.2 and higher. Software Implementation Error. Z-039-0/
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REASON The software validation of version 4.01R1 a software anomaly was found that affected the proper function of a print option. PRODUCT Vitalcom ST Segment Arrhythmis Detection Software Option, an Optional ECG software feature used in conjunction with the Critikon Observer Central Station on which is installed. There are 12 models or catalog numbers of...
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PRODUCT Model 250 NeuroCybernetic Prostheses (NCP) Programming Software Versions a) 4/1; b) 4.4, implanted autonomic nerve stimulator for he treatment of epilepsy. REASON The label insert sheets were printed with the incorrect lot number. CODE Lot numbers a) 23952C; b) 26023C, 27137C, 27735C. Recall #Z-570/571-0. MANFACTURER Cyberonics, Inc., Inc., Houston, Texas. RECALLED BY Manufacturer, by...
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Mountain View Blood Bank 10/5/99 The _____ Procedure, Revision Date 10-26-94, required donors who test repeatedly reactive for HTLV- 1/2, HIV, HBsAg and HCV to be permanent y deferred and the donors notified. Employees lacked adequate training because they were not following this procedure [21 CFR 606.20(b)]. The donor deferral files were not adequate to...
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