Tag

recall

Software Recall

Company: Beckman Coulter, IncDate of Enforcement Report: 5/19/04 Class: II PRODUCT UniCel Dxl 800 Access Immunoassay System, P/N 973100. Recall # Z-0904-04. REASON Software coding error may cause a fatal error message. CODE All software versions prior to version 1.4. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letters on March 29, 2004. Firm initiated...
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Company: Beckman Coulter, Inc.Date of Enforcement Report: 5/19/04 Class: II PRODUCT Coulter LH750 Hematology Analyzer. Part Number 6605632. Recall # Z-0905-04. REASON If a customer enters a dilution factor for Sample B prior to the results from Sample A being transferred to the workstation, the predilute multiplication factor will be applied erroneously to the Sample...
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Company: ADAC Laboratories, MadisonDate of Enforcement Report: 5/19/04 Class: II PRODUCT a) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-9052A-ENG. Recall # Z-0911-04; b) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-0613C-ENG. Recall # Z-0912-04; c) Pinnacle3 Radiation Therapy Planning System, Part Number 9104-2011A Rev. A. Recall # Z-0913-04; d) Pinnacle3 Radiation Therapy Planning System,...
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Company: Baxter Healthcare Renal DivDate of Enforcement Report: 5/19/04 Class: II PRODUCT a) Baxter Renal Software Suite (Renal Link and PD Link). Recall # Z-0901-04; b) Renalsoft software system. Recall # Z-0902-04. REASON There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to...
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Company: Respironics California IncDate of Enforcement Report: 5/19/04 Class: II PRODUCT Esprit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics. Recall # Z-0903-04. CODE All codes. RECALLING FIRM/MANUFACTURER Respironics California Inc., Carlsbad, CA, by technician visit on or about June 1, 2001. Firm initiated recall is complete. REASON Ventilator would spontaneously suspend ventilatory support to...
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Company: Toshiba American Med Sys IncDate of Enforcement Report: 5/12/04 Class: III PRODUCT Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems. Recall # Z-0937-04. REASON Software anomaly. The region of the...
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Company: Hudson Respiratory Care Inc.Date of Enforcement Report: 5/12/04 Class: II PRODUCT Concha IV Plus Heated Humidifier. Recall # Z-0929-04. REASON Software malfunction. CODE All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field. RECALLING FIRM/MANUFACTURER Hudson Respiratory Care Inc, Temecula , CA , by visit...
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Date Recall Initiated: May 5, 2004 Product: Tecan Clinical Workstation configured with the Roche Diagnostics Amplicor CT/NG Analyzer Use: The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia and gonorrhea. Recalling Firm: Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46256-1025 Reason for Recall: A software error...
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Medical Device RecallsClass 1 Recall: Roche Diagnostics COBAS GUI Software for the Tecan Clinical Workstation Date Recall Initiated: May 5, 2004 Product: COBAS GUI Software Interface between the Tecan Clinical Workstation and the COBAS Amplicor Analyzer. Use: The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia and...
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Medical Device RecallsClass 1 Recall: Tecan Clinical Workstation with RoboNet Software Date Recall Initiated: May 3, 2004 Product: Tecan Clinical Workstation configured with the RoboNet Software. Use: The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia, gonorrhea and other tests. An operator controls the Tecan Clinical Workstation...
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Company: Abbott Laboratories, Inc.Date of Enforcement Report: 4/28/04 Class: II PRODUCT ARCHTECT System RS-232 Manual, product list number 06F71- 04, for the ARCHITECT i2000 Processing Module and the ARCHITECT C8000 Processing Module. Recall # Z-0818-04. REASON When using a LIS the software system will send up a test result of up to 20 characters although...
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Company: Gyrus Medical, IncDate of Enforcement Report: 4/28/04 Class: II PRODUCT Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications. Recall # Z-0841-04. REASON The generator may malfunction when used in close proximity to a monopolar generator. CODE Model 744000....
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Company: Spencer Technologies, Inc.Date of Enforcement Report: 4/21/04 Class: II PRODUCT Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the same hardware and software – the change from TCD 100M to PMD 100 is a marketing change)....
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Company: Medex, Inc.Date of Enforcement Report: 4/21/04 Class: III PRODUCT Medex 3000 Series Syringe Infusion Pumps. Recall # Z-0813-04. CODE Model numbers: 3010 (General use pump for use with 3cc to 60cc syringes, 3010a (Pump for use with 1 cc to 60cc syringes), 3010aE (Use with 1cc to 60cc syringes in UK), 3010aVX (Evaluation pump...
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Company: General Electric Medical Systems Information TechnologyDate of Enforcement Report: 3/31/04 Class: II PRODUCT PatientNet Monitoring System – PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx. Recall # Z-0727-04. REASON Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly. CODE All PatientNet Central Stations. RECALLING FIRM/MANUFACTURER General...
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Company: Siemans Medial Solutions USA, Inc CoDate of Enforcement Report: 3/31/04 Class: III PRODUCT Acuson Cypress Echocardiography System. Catalog number 8264604; Recall # Z-0744-04. REASON Software problem – mode does not appear on screen. CODE Serial numbers 73480 through 73535, 71165, 71561, 72532, 73125, and 73292. RECALLING FIRM/MANUFACTURER Siemans Medial Solutions USA, Inc, Plymouth Meeting,...
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Company: Instrumentation Laboratory CoDate of Enforcement Report: 3/31/04 Class: II PRODUCT a) ACL Futura Instrument Analyzer. Recall # Z-0736-04; b) ACL Advance Instrument Analyzer. Recall # Z-0737-04. REASON Software may cause instrument to omit step causing reagent carryover which may effect patient test result. CODE a) Software prior to Version V3-5; b) Software version prior...
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Company: Coherent Inc Laser GroupsDate of Enforcement Report: 3/24/04 Class: I PRODUCT Coherent brand Quattro Diode Laser Systems; A Quattro FAP System. Recall # Z-0357-04. REASON Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated. CODE Serial Numbers/Model Numbers: TFAP0004P-TFAP00048. RECALLING FIRM/MANUFACTURER Coherent Inc...
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Company: Beckman Coulter IncDate of Enforcement Report: 3/24/04 Class: II PRODUCT a) CXP software, Part No. 623560. Recall # Z-0635-04; b) Cytomics MXP Software, Part No. 623688. Recall # Z-036-04; c) Cytomics RXP Software, Part Numbers: 175488, 6418489, 175260, 175261, 175262, 175263, 175264, 175265. Recall # Z-0637-04. REASON Software anomaly. Sample ID and the Run...
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Company:Toshiba American Med SysDate of Enforcement Report: 3/10/04 Class: III PRODUCT Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models. Recall # Z-0546-04. REASON Software anomally causes image slices to be in incorrect order. CODE Flexart systems with software V3.51*R534 to V4.10*R551. Visart systems with software V3.51*R234 to V4.10*R251. Excelart systems with software V4.04*R251 to...
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Company: Varian Medical SystemsDate of Enforcement Report: 3/10/04 Class: II PRODUCT EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader. Recall # Z-0582-04. REASON Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy CODE Serial numbers (Domestic units): 724 215 765 210 212...
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Company: Coherent, Inc.Date of Enforcement Report: 3/3/04 Class: II PRODUCT Quattro FAP System, Class IV multi-wavelength laser diode material processing machine. Recall # Z-0357-04. REASON Performance requirement-safety interlocks malfunction due to improper information included in the software operating the laser CODE None. RECALLING FIRM/MANUFACTURER Coherent, Inc, Santa Clara, CA, by technician visit to install software,...
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Company: Soft Computer Consultants, Inc.Date of Enforcement Report: 3/3/04 Class: II PRODUCT “Softbank II” Laboratory Information System. Recall # B-0841-4. REASON Defects in the design of blood bank software program could result in incorrect patient laboratory records. CODE V.19, V.21, and V.22; Release 3.1.3. RECALLING FIRM/MANUFACTURER Soft Computer Consultants, Inc., Palm Harbor, FL, by telephone...
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Company: Medtronic MiniMedDate of Enforcement Report: 2/18/04 Class: III PRODUCT Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software. Recall #Z-0531-04. REASON A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software. CODE All...
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Company: GVI Technology PartnerDate of Enforcement Report: 2/18/04 Class: III PRODUCT CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version BIA. Recall # Z-0527-04. REASON Due to limitations in the operating software, the acquired scan may not be processed properly. CODE S/Ns: 100 thru 105, and 107 thru 116. RECALLING FIRM/MANUFACTURER GVI...
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Company: Cerner CorporationDate of Enforcement Report: 2/11/04 Class: II PRODUCT Cerner HNA Classic Patient Management (U60)/Patient Linking (PHC) software, HNA Classic 306. Recall # B-0440-4. REASON Blood bank software, which included a defect that could result in the failure to accurately display all alloantibodies when linking or combining medical records for the same patient, was...
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Company: Medtronic MiniMedDate of Enforcement Report: 1/21/04 Class: III PRODUCT Medtronic MiniMed. Model 7311 Solutions Pumps and Meters Software. Recall # Z-0265-04. REASON Accessory software fails to report certain reports following download of data from 712 pump. CODE Version 5.0A. RECALLING FIRM/MANUFACTURER Medtronic MiniMed, Northridge, CA, by visit or FedEx software on CD-rom beginning on...
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Company: General Electric Medical Systems Information TechnologyDate of Enforcement Report: 1/21/04 Class: II PRODUCT Solar 9500 Information Monitor. Recall # Z-0250-04. REASON Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first. CODE Software version 3A. RECALLING FIRM/MANUFACTURER General Electric Medical Systems Information Technology, Milwaukee,...
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Company: Misys Healthcare Systems.Date of Enforcement Report: 1/21/04 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-0235-04. REASON Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by facsimile...
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Company: Urologix, Inc., Date of Enforcement Report: 1/21/04 Class: II PRODUCT Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperplasia). The Prostatron utilizes a transurethral microwave antenna, with simultaneous urethral cooling, to heat the prostate. This heating process is regulated through feedback from...
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Company: Roche Diagnostics Corp.Date of Enforcement Report: 1/21/04 Class: II PRODUCT a) Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R. Recall # Z-0326-04; b) Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R. Recall # Z-0327-04; Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and...
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Company:Minolta Corp.Date of Enforcement Report: 1/14/04 Class: II PRODUCT a) Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger,...
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Company: Information Data ManagementDate of Enforcement Report: 1/9/04 DATE RECALL INITIATED: January 9, 2004 PRODUCT / VERSIONS: IDM Surround System, Software versions 3.4, 3.5, and 3.6 REASON: IDM’s Surround System fails to recognize duplicate batches when used in conjunction with the Abbott PPC (Parallel Processing Center) and the TPC (Total Process Control) mode is utilized....
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 12/24/03 Class: II PRODUCT Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata Upgrade, Syngo Symphony, Syngo Symphony Q, and Syngo Symphony Upgrade. Model numbers 4772906, 7106995, 7104693, 5751438, 7106714, 7104719, 7106425, 7104594, 4772971, and...
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Company: Varian Brachytherary VirginiaDate of Enforcement Report: 12/17/03 Class: II PRODUCT BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Recall # Z-0176-04. REASON The manufacturer’s instructions for using radiation treatment software may cause healthcare practitioner to administer an incorrect treatment to...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 12/10/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0151-04. REASON Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modfy/Reject prompt will cause the order not to be processed by the system. CODE Versions 5.2, 5.23, 5.3 up to...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 12/10/03 Class: I PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-0007-04. REASON Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient’s chart without review. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by facsimile on August...
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Company: Biotronik, Inc.Date of Enforcement Report: 11/26/03 Class: II PRODUCT a) Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. Recall # Z-0076-04; b) Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. Recall # Z-0077-04. REASON Potential for early depletion of Implantable Cardioverter Defibrillator battery. CODE a) Serial Numbers: 7811xxxx;...
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Company: General Electric Medical Systems Information Technology,Date of Enforcement Report: 11/19/03 Class: II PRODUCT Solar 8000M Patient Monitor. Recall # Z-0092-04. REASON Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display,...
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Company: Abbott Laboratories, IncDate of Enforcement Report: 11/19/03 Class: II PRODUCT AEROSET System Software, Catalog 2-95068-01 version 1.02ER000 and Catalog 2-95175-01 AEROSET System Software, version 1.02ER000 Upgrade Kit. Recall # Z-0091-04. REASON Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples. CODE Version 1.02ER000 and...
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Company: Veterans Health Administration Office of InformationDate of Enforcement Report: 11/19/03 Class: II PRODUCT VistA Blood Bank Software. Recall # B-0301-4. REASON Blood establishment computer software that could allow the release of unsuitable blood products was distributed. CODE Version number 5.2, software patch LR*5.2*301. RECALLING FIRM/MANUFACTURER Recalling Firm: Veterans Health Administration Office of Information, Hines,...
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Company: Bayer Corp.Date of Enforcement Report: 11/5/03 Class: II PRODUCT Bayer Rapidpoint 405 Blood Gas Analyzer. Recall # Z-0066-04. REASON Potential for bias shift in p02 values due to air bubble in sample path. CODE Software Versions below 3.1. RECALLING FIRM/MANUFACTURER Bayer Corp., Medfield, MA, by telephone and letter dated September 26, 2003. Firm initiated...
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Company: Roche Diagnostics CorpDate of Enforcement Report: 10/22/03 Class: II PRODUCT Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156. Recall # Z-0012-04. REASON Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the RI reagent is depleted. CODE All units with current software...
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Company: Olympus America Inc.Date of Enforcement Report: 10/22/03 Class: II PRODUCT Olympus ImageManager Software, Common name: Medical image storage device {NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking.) Recall # Z-0047-04. REASON Software malfunction; potential for simultaneous cross-linking of...
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Company: DPC CirrusDate of Enforcement Report: 10/15/03 Class: III PRODUCT Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software. Recall # Z-1138-03. REASON Version 2.6 software was released however, it will not properly handle adjustment slopes. CODE All units. RECALLING FIRM/MANUFACTURER DPC Cirrus, Flanders, NJ, by Recall Technical...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 10/8/03 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-1240-03. REASON Software Defect. CODE Verison 5.3 through 5.3.2. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on July 23, 2003. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 466. DISTRIBUTION Nationwide.
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Company: Philips Medical SystemsDate of Enforcement Report: 9/24/03 Class: II PRODUCT HeartStart XL Defibrillator Monitor. Model M4735A. Recall # Z-1226-03.M CODE Units with software versions A.02.00 or greater. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA, by letter on September 2, 2003. Firm initiated recall is ongoing. REASON Instructions for use include additional information on configuration...
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Company: Philips Medical SystemsDate of Enforcement Report: 9/24/03 Class: II PRODUCT a) Gyroscan ACS-NT with software versions R6x, R7x, R8x. Recall # Z-1227-03; b) Gyroscan NT-Intera. Recall # Z-1228-03; c) Gyroscan Intera 1.0T & 1.5T. Recall # Z-1229-03. REASON Patient burns from cables near or in contact with the patient during use. CODE a) 6808,...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 9/17/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1217-03. REASON Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported. CODE Version 5.2 through 5.3.2 using LabAccess Results. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on...
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Company: Harvard Clinical TechnologyDate of Enforcement Report: 9/17/03 Class: II PRODUCT Harvard 2, Dual Infusion Pump (P/N 2002-001). Recall # Z-1208-03. REASON Under specific sequence conditions, the unit may appear to be infusing, but is not. CODE Software versions V1.2R or earlier. RECALLING FIRM/MANUFACTURER Harvard Clinical Technology, South Natick, MA, by letter on August 11,...
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