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...Read More

/docs/GHTF-QSRiskMgmtGuidance-sg3n15r82005.pdfRead More

/docs/TransfusionSafteyManagementSystems-FDApresentation09-Mar-06.pdfRead More

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...Read More

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...Read More

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...Read More

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,...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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.....Read More

/Docs/SCPRed/SoftwareCPR-Newsletter0106.PDFRead More

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...Read More

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....Read More

/docs/FDA-PATPresentationwatts_3_2005.pdfRead More

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...Read More

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,...Read More

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....Read More

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22267.pdfRead More

http://www.21cfrpart11.com/pages/sol_prov/solution_providers.htmRead More

Recipient: Visual Telecommunications NetworkProduct: ViTelCare Trutle Home Patient Monitoring Systems Date: 9/13/05 Software used in the Turtle 600 and Turtle 800 devices has not been validated and a risk analysis has not been conducted for the finished devices [21 CFR 820.30(g)]. FDA District: Baltimore District OfficeRead More

Recipient:Guidant CorpProduct: TA-200 Thermal Angel Blood and IV Fluid Infusion Warmer Date:9/22/05 There are no corrective and preventive actions to change design control procedures to identify or prevent memory overflow or similar software programming problems from recurring. Software used as part of production and the quality system has not been fully validated for its intended...Read More

The link provided is a pdf of slides on validation of design tools presented by Carl Wyrwa of Beckman at the November 2005 ADVAMED FDA Conference. These are provided with his permission. Validation Of Design Tools Presentation Carl Wyrwa 03Nov2005 V9Read More

The link provided is a pdf of slides on software maintenance presented by Carl Wyrwa of Beckman at the November 2005 ADVAMED FDA Conference. These are provided with his permission. Software Maintenance Presentation Carl Wyrwa 03Nov2005 V9Read More

/docs/GlucoseMeterFDASafetyAlert102605.pdfRead More

Company: Abbott Diabetes Care, Inc..Date of Enforcement Report: 6/7/05 Class:I PRODUCT Abbott Diabetes Care, Inc. Blood Glucose Meters REASON The recalled Abbott blood glucose meters can inadvertently switch the glucose readings from mg/dL, the U.S. standard to mmol/L, the foreign standard. The unit of measure could change in the course of setting the time and...Read More

Company: Misys Healthcare Systems.Date of Enforcement Report: 9/29/2005 Class:II PRODUCT Misys Laboratory version 6.1 – Microbiology Module, Recall # Z-0088-06 REASON Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000 the system will file the number 100 instead of number 100,000. CODE All...Read More

Company: Baxter Healthcare Corp.Date of Enforcement Report: 10/26/2005 Class:II PRODUCT Baxter’s Patient Care System (BPCS) software, Pharmacy Management – Inpatient – product code 2M5013 and Point of Care – product code 2M5014; made in Canada, Recall # Z-0061-06 REASON If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached...Read More

/Docs/ADVAMEDSoftware513(g)sFDASlides110205.pdfRead More

Company: Beckman Coulter, Inc., .Date of Enforcement Report: 9/6/2005 Class:I PRODUCT Synchron LX Systems Version 4.5 Operating Software, Recall # Z-0009-06 REASON Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine...Read More

Company: Datascope Corp.Date of Enforcement Report: 10/5/2005 Class:III PRODUCT Elx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System. Recall # Z-1576-05 REASON An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek Elx800 programming specifications for the ORTHO HCV Version...Read More

Company: Datascope Corp.Date of Enforcement Report: 9/28/05 Class:II PRODUCT Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. Part Number 0040-00-0366-20, Recall # Z-1567-05 REASON The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse. CODE Version 8.02 RECALLING FIRM/MANUFACTURER Datascope Corp, Mahwah, NJ, by letter...Read More

Recipient: Guidant CorpProduct: Insignia Pacemaker Date: 9/22/05 There are no corrective and preventive actions to change design control procedures to identify or prevent memory overflow or similar software programming problems from recurring. Software used as part of production and the quality system has not been fully validated for its intended use according to an established...Read More

Company: Sammons Preston RolyanDate of Enforcement Report: 9/14/05 Class:III PRODUCT TM-300 Traction System; an Rx software driven device used for patient traction, Product No. A501-009, Recall # Z-1444-05 REASON The traction device may malfunction, producing oscillation and a jerking motion. CODE Serial numbers 1000 through 1207 RECALLING FIRM/MANUFACTURER Recalling Firm: Sammons Preston Rolyan, Bolingbrook, IL,...Read More

Company: Philips Medical Systems (Cleveland) Inc.Date of Enforcement Report: 9/7/05 Class:II PRODUCT a) Brilliance CT System, 40 channel configuration using version 1.2 software, Recall # Z-1409-05; b) Brilliance CT System, 16 Power configuration using version 1.2 or 1.2.1 software, Recall # Z-1410-05; c) Brilliance 16, 10, and 6 configuration (water cooled version) using 1.0. 1.1,...Read More

Company: Beckman Coulter, IncDate of Enforcement Report:9/7/05 Class:II PRODUCT Aqueduct Hematology Workflow Manager, software, Part Number AQDCT, Recall # Z-1440-05 REASON Potential for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aqueduct Workflow...Read More