Category

News
Company: Mediware Information Systems, Inc.Date of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0667-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...
Read More
Company: Mediware Information Systems, IncDate of Enforcement Report: 1/23/02 Class: III PRODUCT Hemocare Blood Bank Data Management System, Recall # B-0666-2. REASON Defects in the design of blood bank software programs could result in the release of unsuitable blood products. CODE Version 5.1, 5.2 and/or 5.2a. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY, by...
Read More
Company: Sunquest Information Systems, IncDate of Enforcement Report: 1/23/02 Class: II PRODUCT FlexiLab? Blood Bank and Blood Donor Software (3 versions), Recall # B-0627-2. REASON Blood establishment computer software that could allow the release of unsuitable blood products was distributed. CODE Version numbers 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ,...
Read More
Company: Sysmex CorpDate: 01/22/2002 Product name: Clinical laboratory diagnostic devices, including hematology, reticulocyte, urinalysis and coagulation analyzers Failure to establish and maintain documented procedures to control and verify the design of the device in order to ensure that specified design requirements are met, as specified in 21 CFR 820(a)(1). For example, there were no procedures...
Read More
Company: Siemens Medical Systems, IncDate of Enforcement Report: 1/16/02 Class: III PRODUCT Autoperfusion Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0427-02. REASON The software did not save oblique data correctly...
Read More
Company: Siemens Medical Systems, INCDate of Enforcement Report: 11/16/01 Class: III PRODUCT Autoperfusion Software, which includes The Cardiac Review (Profile Review) application, used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0428-02. REASON...
Read More
FDA withdrew recognition of this standard in May 2007 after it was obsoleted and replaced by ISO 62304. On Jan 14, 2002 FDA issued an update to their list of recognized standards for use by the Office of Device Evaluation. A new software standard was recognized. This is the AAMI/ANSI SW 68 Medical Device Software...
Read More
Company: Pharmaceutical Distribution SystemsDate: 01/03/2002 Product: Drug products Failure to exercise appropriate controls over and to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment used in the manufacturing, processing, and packaging of a drug product according to a written program designed to assure proper performance (21 CFR 211.68) in that, the installation qualification...
Read More
/docs/SCPRed/SoftwareCPR-Part11GlossaryGuidanceCommentRecord.PDF
Read More
Company: Natural Technology Inc.Date: 12/14/01 Product: Drug products Failure to maintain records of calibration checks and inspections of automatic, mechanical, or electronic equipment [21 CFR 211.68(a)]. For example, incubator and refrigerator thermometers associated with equipment that stores microbiological media have not been calibrated. FDA District: Dallas District Office
Read More
Company: Medical Device Services Inc.Date: 12/13/2001 Product Name: Single use medical devices, such as general surgery, orthopedic, laparoscopic and cardiovascular instruments, including biopsy forceps, needles, burrs, drill bits, saw blades, trocars, retractors, blood pressure cuffs, catheters and guidewires Failure to validate computer software for its intended use according to an established protocol prior to approval...
Read More
Company: Cardinal Enterprises Inc. Date: 12/07/2001 Product: Drug products Master production and control records are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated and signed by a second person. Master production records are generated from a computer as electronic records without any apparent controls to assure...
Read More
Company: Abbott Laboratories, IncDate of Enforcement Report: 11/28/01 Class: II PRODUCT The Abbott AxSYM System is a fully automated Immunoassay analyzer designed to perform Microparticle Enzyme Immunoassay (MEIA), Fluorescence Polarization Immunoassay (FPIA), Radiative Energy Attenuation (REA) Assay Technology, and Ion Capture (IC) Immunoassay Technologies. The AxSYM System performs random access, continuous access, and STAT processing...
Read More
Company: Multidata Systems International Corp.Date of Enforcement Report: 11/28/01 Class: II PRODUCT Radiation Treatment Planning Decision Support System (DSS), Recall # Z-0213-2. REASON The software calculates radiation overdoses that require human intervention to detect and prevent injury to radiation therapy patients. CODE All versions. RECALLING FIRM/MANUFACTURER Multidata Systems International Corp., St. Louis, MO, by letter...
Read More
Company: Radionics, A Division of Tyco HealthcareDate of Enforcement Report: 11/21/01 Class: II PRODUCT Radionics XKnife RT Software, Recall # Z-0275-2. REASON Software error may cause incorrect jaw settings for a record/verify system. CODE Version 1.02 and lower. RECALLING FIRM/ MANFACTURER Radionics, A Division of Tyco Healthcare, Billerica, MA, by telephonebetween 9/17/2001 and 18/01. Firm...
Read More
http://www.21cfrpart11.com/pages/sol_prov/solution_providers.htm
Read More
Company: Novametrix Medical Systems, IncDate of Enforcement Report: 11/7/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0216-2, Novametrix NICO Monitor, Model 7300 with software versions below 4.3 REASON: Monitor may miscalculate Pulse Rate and Oxygen Saturation (SpO2) values. MANUFACTURER/RECALLING FIRM: Novametrix Medical Systems, Inc., Wallingford, CT RECALLED BY: Recalling firm by letter on 7/9/01 FIRM...
Read More
Company: Marconi Medical Systems, IncClass: II Date of Enforcement Report: 10/31/01 RECALL NUMBER, PRODUCT AND CODE: Z-0181-2, Marconi MX8000 Computed Tomography X-ray System, Codes: All Marconi MX8000 CT Scanners, running with Version 2.0 and 2.01 software. REASON: Software in version 2.0 / 2.01 software may lead to improper patient treatment. MANUFACTURER/RECALLING FIRM: Marconi Medical Systems,...
Read More
Company: Bunnell Inc.Date: 10/29/01 Product: High frequency jet ventilators and accessories for neonatal use Failure to validate processes that cannot by fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example the compliant handling software program, ultrasonic sealing procedure, leak testing procedure, and injection molding procedure have not been validated....
Read More
Company: Dade Behring Marburg GMBHDate of Enforcement Report: 10/24/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0013-2, Behring Coagulation System (BCS) Coagulation Analyzer. Codes: Software Version 2.2 Code OVIO03 REASON: Falsely shortened APTT value. MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH, Marburg, Germany RECALLED BY: Dade Behring, Inc., Newark, DE, by letter on 6/25/01 FIRM INITIATED...
Read More
Company: Marconi Medical Systems, IncDate of Enforcement Report: 10/24/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0057-2, Marconi MX8000 Computed Tomography X-ray Codes: All Marconi MX8000 CT Scanners running with Version 2.0 sofware. REASON: A software anomaly in ver 2.0 software may result in improper patient diagnosis. MANUFACTURER/RECALLING FIRM: Marconi Medical Systems, Inc., Highland Heights,...
Read More
Company: Nihon Kohden, IncDate of Enforcement Report: 10/24/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0177-2/Z-0178-2, Procyon Bedside Monitors, Models BSM-4104A and BSM- 4114A. Codes: Models BSM-4104A and BSM-4114A Bedside Monitors. REASON: Software causes infusion rate 2.2 times proper rate. MANUFACTURER/RECALLING FIRM: Nihon Kohden, Inc., CA RECALLED BY: Recalling firm by telephone and letter on...
Read More
Company: Siemens Medical Systems, IncDate of Enforcement Report: 10/24/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0031-2, Motion Electronics Computer Chassis (MECC) Backplanes installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL Codes: MECC Backplane “2104938 REV C” —...
Read More
Company: Sorenson Development IncDate: 10/17/01 Product: Infusion pumps and other medical devices Failure to validate processes with a high degree of assurance where the results cannot be fully verified by subsequent inspection and testing, and have those processes approved and documented according to established procedures, as required by 21 CFR 820.75(a). Specifically, revalidation of the...
Read More
Company: TegimentaDate of Enforcement Report: 10/17/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0008-2, COBAS Integra 400 laboratory clinical chemistry analyzer, Model 400, Catalog number 1045199. All serial numbers of analyzers lower than 38-2606. Serial numbers of 38-2606 or higher have already been updated with software revision upgrade 4. REASON: If the operator fails to...
Read More
Company: Bayer CorporationDate of Enforcement Report: 10/10/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-1223-1, Software versions AE through AL (except AI) for the Bayer Advia Centaur Automated Chemiluminescence Immunoassay System. The affected software was distributed as a component of the Advia Centaur Automated Chemiluminescence Immunoassay system. Codes: Software versions AE through AL, except version...
Read More
Company: Grand RapidsDate: 10/1/01 Product: Thumper cardiopulmonary resuscitator Your response to FDA-483 point #6 regarding 21 CFR Part 11 – Electronic Records is not adequate as explained in more detail below. 21 CFR Part 11 During the FDA inspection it was discovered that electronic records are used to establish the firm’s Complaint Files, 21 CFR...
Read More
Recipient:Christ Hospital Product: blood bank Date: 9/27/2001 During an inspection of your unlicensed blood bank, conducted on July 26, 30 and August 1, 2001, our investigator documented violations of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act and Title 21, Code of Federal Regulations 211 and 600-680, as follows: Failure to conduct validation...
Read More
Recipient:Dentsply International, Inc Product: dental handpieces and dental accessories Date: 9/26/2001 The inspection revealed that these 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 for manufacturing, packing, storage, or installation are not in conformance with the Quality System regulation...
Read More
WITHDRAWN BY FDA Feb 2003 as not representative of their current thinking. FDA has released it as a draft validation Guidance on Part 11 Electronic Records; Electronic Signatures. These guidance documents were developed by FDA’s Part 11 Compliance Committee. This is a draft, and industry comments will be important in shaping the final guidances. Submit...
Read More
http://www.fda.gov/cder/regulatory/ersr/FDARegional/ectd.htm
Read More
Company: SIEMENS MEDICAL SYSTEMS, INCDate of Enforcement Report: 9/19/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1106-1 – Z-1108-1 Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Codes: a) Model 4380213 – E.CAM Gantry Single Head, serial numbers 0001 through...
Read More
Company: B. Braun Medical Inc.Date: 9/17/01 Product: Disposable IV sets Failure to validate computer software used to (1) control the Eto sterilization process, for example, _____ cycles, and (2) control the _____ _____) employed in the manufacture of disposable IV sets, to ensure the software will perform for its intended use. 21 CFR 820.70(i). FDA...
Read More
Company: Cleveland Medical Devices Inc.Date: 9/17/01 Product: Wireless medical telemetry monitoring systems No documented corrective and preventative action for software bugs found during retrospective validation. Validation testing revealed several responses that were unexpected and may potentially adversely effect the performance of the Model 15 The above stated inspection revealed that your devices are adulterated within...
Read More
Company: SIEMENS MEDICAL SYSTEMS, INC.Date of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1105-1/Z-1107-1 Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine proceduresCodes: a) Model 4380213 – E.CAM Gantry Single Head, serial numbers 0001 thru 2016 b) Model...
Read More
Company: WELCH ALLYN PROTOCOL, INCDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1049-1 Acuity Central Monitoring Stations with software versions 4.03.00, 4.03.01,4.03.02, 4.03.03, 4.03.04, and 4.03.05 when connected to VHF/UHF telemetry units CODES: software versions 4.03.00, 4.03.01, 4.03.02, 4.03.03, 4.03.04, and 4.03.05 REASON: Incorrect Visual Display MANUFACTURER/RECALLING FIRM: WELCH ALLYN PROTOCOL,...
Read More
Company: Applicare Medical ImagingDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0857-1/Z-0858-1 RadWorks Software Version 5.1 with Software Patch 5 or 7, and RadWorks WebViewer Software Verion 5.1 running on RadWorks 5.1 Software Patch 5 or 7; picture archival and communications system; Applicare Medical Imaging B.V., Zeist, The Netherlands Codes: RadWorks...
Read More
Company: Dade Behring Marburg GMBH MarburgDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0906-1 Behring Coagulation System (BCS) software CODES: Model OVIO03, Version 2.2 REASON: Leak of piston pump valve introduces air bubbles. MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg RECALLED BY: Dade Behring, Inc., Newark, DE, by letter. FIRM INITIATED...
Read More
Company: GE Medical Systems, Information TechnologiesDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1078-1 Clinical Information Center Software. The brand name was Marquette when the product was initially distributed. CODES: All devices with V.2 and later revisions of the software. REASON: Device can improperly restart resulting in no alarms or information...
Read More
Company: SANGUIN INTL., INCDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1048-1 Medusa 2000 MED20SP Link Software Versions 1.2 and 1.3 The software Medusa 2000 is an interface link to the Ortho Summit Processor (OSP) which is a mass processing device for microplate based assays [tests for viral markers by ELISA]....
Read More
Compnay: Siemens Medical Systems, IncDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0851-1 ICON Profile Processing Software used on the ICON P workstations designed for use with E.CAM Gamma Camera Systems to conduct cardiac Tomo and SPECT applications; 60195-5203. Codes: All E.CAM gamma cameras with the Profile option with ICON-P workstations...
Read More
Company: Total Medical Information Management Systems Inc.Date: 9/7/01 Product: Picture archiving and communications systems software During an inspection of your establishment located in Longwood, Florida on August 6-7, 2001, FDA Investigator Ronald T. Weber determined that your establishment is a manufacturer and distributor of picture archiving and communication systems software, which is a medical device...
Read More
Company: AGILENT TECHNOLGIES Date of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0948-01/Z-0949-01 Agilent Technologies (formerly Hewlett Packard Co.) (A)Anesthesia Monitoring Systems, M1165A, M1166A, M1167A, M1175A, M1176A, M1177A with Release C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S Firmware Revision level: Only EEPROM Nos.: M1059-81242...
Read More
Company: Baxter Healthcare CorporationDate of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: B-1332-1, Amicus Separator Apheresis Instrument with software version 2.50 REASON: Blood collection device may return an inappropriate volume of plasma to a donor during an apheresis procedure. MANUFACTURER: Baxter Healthcare Corporation, Largo, FL RECALLED BY: Baxter Healthcare Corp., Round Lake,...
Read More
1 73 74 75 76 77 85

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

Corporate Office

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