Category

News
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.
Read More
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.
Read More
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.
Read More
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...
Read More
/Docs/CBERnew510kparadigmslides4perpage.pdf
Read More
.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...
Read More
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....
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
Failure to establish adequate written-recall procedures and to validate the computer software programs designed to facilitate recall of distributed drug products.
Read More
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...
Read More
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...
Read More
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...
Read More
.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
Read More
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....
Read More
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.
Read More
… 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
Read More
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.
Read More
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,...
Read More
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...
Read More
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;
Read More
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....
Read More
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...
Read More
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...
Read More
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....
Read More
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 _____...
Read More
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:.
Read More
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...
Read More
Failure to review, evaluate and investigate complaints involving the possible failure of a device to meet any of its performance specifications; failure to thoroughly evaluate and investigate complaints; and failure to validate software used in tracking and trending service and complaints. 4. Failure to validate software used in tracking and trending service and complaints. For...
Read More
4) Failure to produce documented evidence to demonstrate the computer controlled/automated system for the manufacturing of liquid oxygen and nitrogen has been validated.
Read More
The Food and Drug Administration (FDA) inspected your medical practice on September 3, 4 and 15, 1997, and determined that you are using an unapproved excimer laser system assembled by _____ an engineering consultant with _____ and representatives of _____ This laser system contains software developed by _____ with your input into its design. This...
Read More
You failed to respond to calibration failures of the ultraviolet (UV)/visible spectrophotometer as required by your procedures. Instruments were not taken out of service, logbooks did not reflect passing/failing calibrations, certificates of calibrations were incomplete, there was no investigation into the cause of failures and no record was maintained of the corrective action taken as...
Read More
Failure to establish and implement an adequate complaint handling system. Although the computerized complaint system used by your firm allows input from all departments, there is no system in place to assure that all service records are reviewed and evaluated for potential inclusion in the complaint handling system.
Read More
We acknowledge that you have destroyed key components of the _____ and thus have terminated your _____ of this device. Please advise this office, in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to prevent recurrence in future _____ of violations similar to those listed above....
Read More
Failure to validate the heat sealing equipment; failure to validate the software in use to calculate GPL and MPL unit values; failure to provide adequate documentation to assure that the product will maintain its functionality throughout its labeled expiration date; and the quality assurance program failed to respond to device quality problems identified as a...
Read More
1. Failure to validate major equipment used in the manufacture of medical devices (i.e. computer-driven Kiwa mills, Mori Seiki SL2B lathe, and Citizen lathes);
Read More
Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria; failure to establish and maintain an adequate organization structure; and failure of the device master record to include, or refer to the location of, for each type of device, device...
Read More
a) Failure to validate finished device testing software, some of which were incorrectly programmed. b) Test software failed to contain a test process/calculation to assure that finished device accuracy specifications were met. e) Failure to establish written and approved manufacturing procedures for finished device test software for MRX multi board and single board devices.
Read More
9/30/97 EZ-Flow 480 Ambulatory Infusion Pump 1058 devices. Defective software may cause over infusion when using the PCA mode. 1/9/98 confirmed a patient death due to a software logic error related to use in the patient controlled analgesia (PCA) mode caused the lethal dose of morphine sulfate. Two non-fatal incidents in 1996 also occurred.
Read More
1 77 78 79 80 81 82

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020

To pre-register and get info on deep discounts or if you have questions, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.