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Company: Misys Healthcare Systems, Date of Enforcement Report:5/17/2006 Class:lI PRODUCT Misys Laboratory Blood Bank Module, Version 6.1, Recall # B-1065-6 REASON Defects in the design of software could result in data being out of sync with the accession number, patient and/or units displayed on the screen. CODE Version 6.1 RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson,...
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Company: AGFA Corporation., Date of Enforcement Report:5/17/2006 Class:lI PRODUCT CR DX-S, DX-S, Computed radiography system (Digitizer), Software versions: STR1102B and below, Recall # Z-0855-06 REASON Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop CODE Serial numbers: SN10001-SN1079 RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corporation, Greenville,...
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http://webstore.iec.ch/webstore/webstore.nsf/$$search?openform
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Company: Respironics California Inc Date of Enforcement Report:5/10/2006 Class:l PRODUCT Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. It utilizes an internal compressor to generate compressed air for delivery to the...
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Company:Baxter Healthcare Corporation, Date of Enforcement Report:5/10/2006 Class:lI PRODUCT a) RenalSoft Observational Study v.2.0 – HD Module, PD Module and Medical Record Module; clinical data management software, Recall # Z-0831-06; b) RenalSoft v.1.1 – PD Module; clinical data management software, Recall # Z-0832-06; c) Renal Software Suite v.3.1 – HD Module; clinical data management software,...
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Company: Siemens Medical Solutions USA, Inc, Date of Enforcement Report:5/3/2006 Class:lI PRODUCT Somatom Sensation CT Systems, Sensation 10, model number 7543015, Sensation 16, model number 7393114, Sensation 64, model number 8377520, and Sensation Open model number 8872017, Recall # Z-0797-06 REASON Firm became aware of a potential problem that could affect scan results and require...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report:5/3/2006 Class:lI PRODUCT AXIOM Artis X-ray systems running software versions VB11K and VB22-G, AXIOM Artis FC model number 5904433, AXIOM Artis BC model number 5904649, AXIOM Artis MP model number 5904466, AXIOM Artis FA model number 5904441, AXIOM Artis BA model number 5904656, AXIOM Artis TC...
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Company:Neurotone Systems Inc..Product: RelaxPak, Neurotone III and Neurotone III D Cranial Electrotherapy Stimulator Date: 4/10/2006 Failure to establish, and maintain procedures for monitoring and control of parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75. [FDA-483 Item 4). Where the process cannot be fully...
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Company: Boston Scientific Target, Date of Enforcement Report:3/15/2006 Class:lI PRODUCT ILab Utrasound Imaging System, software controlled Imaging Catheter, Model Numbers M0004EPiL120CART0, H749iLab120CART0, H749iLab120CARTD0, H749iLab120CARTR0, H749iLab120INS0, Recall # Z-0789-06 REASON Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters...
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http://www.fda.gov/cdrh/oivd/presentations/042004-callaghan-software.html#footnote_2
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http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm
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http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm
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Company:Fischer Imaging Corporation, Date of Enforcement Report:4/19/2006 Class:lI PRODUCT SenoScan Full Field Digital Mammography System, Product number 94001G-3, 105200G, Recall # Z-0757-06 REASON Software upgrade to preclude lost images during mammography procedure. CODE Software versions earlier than 5.2.2 RECALLING FIRM/MANUFACTURER Fischer Imaging Corporation, Denver, CO, by letter on March 27, 2006, firm initiated recall is...
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Company: Sonosite, Inc. Date of Enforcement Report:4/12/2006 Class:lI PRODUCT SonoCalc IMT 3.0, windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media thickness (IMT) based on average thickness of the carotid artery, Recall # Z-0713-06 REASON When SonoCalc IMT...
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Company: bioMerieux, Inc, Date of Enforcement Report:4/12/2006 Class:lI PRODUCT BacT ALERT Classic 120 System and 240 System, Recall # B-0865-6 REASON BacT/ALERT Classic Systems, with a software glitch or defect, were distributed. CODE All Models RECALLING FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC, by letter dated September 17, 2004, firm initiated recall is ongoing. VOLUME OF PRODUCT...
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Company: Baxter Healthcare, LLC Date of Enforcement Report:4/6/06 Class:Il PRODUCT a) Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. — Common Name: Blood gases, electrolyte and blood pH test system, Recall # Z-0682-06; b) Brand Name: RapidLab 1200 System, Model 1245, Part...
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This report was from an independent panel commissioned by Guidant corporation after Guidant received significant press for failure to take timely corrective action, including lack of clinician notification, of low probably known defects that could and did lead to deaths. This was focused in cardiac rhythm management products such as implantable pacemakers and defibrillators. The...
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Company: LMS Medical Systems Ltd, Date of Enforcement Report:5/3/2006 Class:lI PRODUCT CALM software. This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data...
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Company: Hospira Inc., Date of Enforcement Report:3/15/2006 Class:lI PRODUCT Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09, Recall # Z-0601-06 REASON Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen. CODEList numbers 12384-04, software version 4.08 and 4.09 RECALLING FIRM/MANUFACTURER Hospira, Inc., Morgan Hill , CA ,...
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/docs/TransfusionSafteyManagementSystems-FDApresentation09-Mar-06.pdf
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Company: Beckman Coulter, Inc., Date of Enforcement Report:3/8/2006 Class:lI PRODUCT UniCel Dxl 800 Access Immunoassay System, Recall # Z-0583-06 REASON The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances) CODESoftware Versions 2.2.1 and earlier RECALLING FIRM/MANUFACTURER...
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Company: Fujifilm Medical System USA, Inc., Date of Enforcement Report:3/222006 Class:Il PRODUCT Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS, Recall # Z-0622-06 REASON Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.. CODE Versions 3.1.0 and 3.1.1 RECALLING...
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Company: Nova Biomedical Corporation., Date of Enforcement Report:1/27/2006 Class:Ill PRODUCT a) Star Profile Critical Care (CCX) Analyzer Catalog Number: 35942, Recall # Z-0576-06; b) Star Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413, Recall # Z-0577-06; c) CCX Operating Software, Version 4.08, Recall # Z-0578-06 REASON Analyzers may fail to perform scheduled automatic two-point...
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Company: Toshiba America Medical Systems, Inc., Date of Enforcement Report:3/8/2006 Class:Il PRODUCT Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film device for diagnostic fluoroscopic imaging, Recall # Z-0533-06 REASON Systems are defective under 21 CFR 1003.2 in that they may deliver radiation unintended to their use. CODE Serial numbers D4622390, D4622394, D4623349, D4612382,...
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Company: DiasorinDate of Enforcement Report:3/12006 Class:lI PRODUCT The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1), Recall # Z-0557-06 REASON Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay...
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Company: Lumenis, Inc.Date of Enforcement Report:2/22/2006 Class:lI PRODUCT Lumenis brand Lumenis One System with Multi-Spot Nd: YAG, LightSheer and Universal IPL, Recall # Z-0529-06 REASON Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns. CODE Software versions lower than 2.02. All serial numbers; All codes RECALLING FIRM/MANUFACTURER Recalling...
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Recipient: National Genetics Institute.Product:HIV-1 and Hepatitis C virus nucleic acid tests Date: 1/17/2006 FDA District:Los Angeles District Office Failure to validate computer software used in production; failure to validate the quality system; failure to document validation activities and results; failure to make adequate provisions for monitoring laboratory test procedures and instruments; failure to maintain written...
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Company: Beckman Coulter, Inc.Date of Enforcement Report:2/8/2006 Class:lIl PRODUCT a) OULTER LH 700 Series Hematology Analyzer, PN 6605632 and 6605632R, Recall # Z-0474-06; b) COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R Recall # Z-0475-06 REASON There is a risk of sample misidentification when processing samples in the...
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The EU is now close to release of a revision of the Medical Device Directive (MDD). The full text with change marks is at the link provided. The MDD has expanded clause 12.1 into an (a) and (b) sub-clause with the latter specifically addressing software and the former being the original 12.1. The text of...
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Company: Tri State IncorporatedDate of Enforcement Report:2/12006 Class:lI PRODUCT Oxygen Compressed USP, size M6, D, E, C, M, and MN cylinders, Recall # D-144-6 REASON cGMP deviations: FDA inspection of the recalling firm found that the Auto HP computerized filling system is not validated and there is no way to verify the automated vent and...
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Company: Datascope Corp.Date of Enforcement Report 2/1/2006 Class:lI PRODUCT Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor, Recall # Z-0437-06 REASON Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off. CODE All Panorama Central Station containing software versions 8.1.6 through 8.2 RECALLING...
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Company: Roche Diagnostics Corp.Date of Enforcement Report:2/1/06 Class:II PRODUCT a) Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.), Recall # Z-0417-06; b) Roche brand Accu-Chek Aviva Meter Only Kit; Catalog number 04532279001. (Distributed within the U.S.), Recall # Z-0418-06; c) Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed...
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Larry Pilot, lead attorney on behalf of Utah Medical, recently gave a presentation on this case. His slides are available at the link provided with his permission. In this case FDA cited Utah Medical Products for process and production software validation issues and was seeking an injunction. Utah Medical won in court and FDA decided...
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Company: Beckman Coulter Inc.Date of Enforcement Report:1/25/2006 Class:II PRODUCT Cytomics FC500 Cytometer with CXP Software, Part Numbers 629636 629637, Recall # Z-0380-06 REASON Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0. CODE CXP Cytometer Software Version 2.0 (acquisition software...
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Company: Stentor, Inc.Date of Enforcement Report:1/25/2006 Class:lI PRODUCT “iSite” PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3, Recall # Z-0399-06 REASON When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the patient/exam selected and shown may be different on the radiologist console and...
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Company: Instrumentation Laboratory Co., Lexington, MA.Date of Enforcement Report:1/25/2006 Class:lI PRODUCT GEM PREMIER 3000, Point-of-care blood analyzer. Recall # Z-0378-06 REASON Software error may report higher results for glucose and lactate. CODE Serial numbers starting with 18412 RECALLING FIRM/MANUFACTURER nstrumentation Laboratory Co., Lexington, MA, by letter dated December 16, 2005. Firm initiated recall is ongoing...
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Company: Abbott Laboratories, Inc.Date of Enforcement Report:1/25/2006 Class:lI PRODUCT ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, Recall # Z-0398-06 REASON System software assigns a calibrator default volume of 2.OuL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0...
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Recipient: LifeScan Inc.Product: OneTouch Ultra and OneTouch UltraSmart Blood Glucose Readers Date: 12/7/20055 Your October 6, 2005 response also describes the need to validate changes planned for your electronic complaint handling system. Again, a timeline for the completion of your validation study was not provided. The validation of your complaint handling system and the training...
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Recipient: Shelhigh Inc.Product: Porcine Pulmonic Valve Conduits, Aortic Valve Conduits, Mitral Valve Conduits and other devices Date:12/14/05 Failure to obtain premarket approval prior to offering products for sale; failure to follow written procedures for design control; failure to follow written procedures for design validation to include a risk analysis; failure to validate corrective and preventive...
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Recipient:Rite-Dent Manufacturing CorpProduct:Alginate impression material, zinc phosphate cement, polycarboxylate cement and other dental OTC devices Date: 12/2/05 Your firm failed to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purpose(s) and is capable of producing valid results. Each manufacturer shall maintain...
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Company: Respironics California, Inc.Date of Enforcement Report:1/18/2006 Class:lI PRODUCT The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is...
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Company: Philips Medical Systems North America Co.Date of Enforcement Report:1/18/2006 Class:lI PRODUCT Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging. Recall # Z-0358-06 REASON The Gyroscan NT MRI system has a computer software problem which results in images from one patient being placed into another patient’s image record.....
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Recipient: Gambro Dasco S.p.A.Product:Electromechanical dialysis control systems Date: 1/5/06 Letter acknowledges receipt of firm’s Oct. 24, 2005, response to FDA 483 but deems it inadequate. Letter notes that until alleged violations are corrected, the FDA may take steps to keeping imported devices in detention. Letter also includes alleged reporting violations. For example, review of the...
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Company: Toshiba American Med Sys, Inc.Date of Enforcement Report:1/4/2006 Class:II PRODUCT a) Digital Radiography System Model DFP8000D, Recall # Z-0324-06; b) Digital Radiography System, Model DFP-8000D/FPD, Recall # Z-0325-06 REASON To correct a software problem that caused the LV images, which were acquired for 15 seconds at the end of the examination, to be lost....
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Company: Ortho-Clinical Diagnostics.Date of Enforcement Report:11/16/2005 Class:lI PRODUCT Vitros ECi Immunodiagnostic System, sold as Catalog #863 3893; Catalog #192 2814 (Vitros ECiQ), and Catalog #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated...
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Company: Diasorin Inc.Date of Enforcement Report: 11/16/2005 Class:II PRODUCT ETI-LAB Applications Disk (for programming Bio-Rad HIV-1/HIV-2 Plus O EIA Assay), Recall # B-0140-6 REASON Defect in the design of HIV-1/2 testing software resulting in an incorrect incubation temperature. CODE Version 1.0 RECALLING FIRM/MANUFACTURER Diasorin, Inc., Stillwater, MN, by telephone and letter dated May 13, 2004....
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Company: Hemosense Inc.Date of Enforcement Report:11/16/2005 Class:II PRODUCT Hemosense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21, Recall # Z-0132-06 REASON A software problem that may cause the INRatio meter to incorrectly display ‘INR>7.5′ test message under a particular use condition. 7.5’ test message under a particular use condition.” name=prdReason0 CODE Serial Numbers: 044609678,...
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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Boston, MA)

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Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
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3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

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  • Americas: 11-13 February 2025
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See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

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Instructor: Dr Peter Rech, 2nd instructor (optional)

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