Company:St Jude Medical Date of Enforcement Report:12/27/2006 Class:ll PRODUCT a) St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510, Recall # Z-0296-2007; b) St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650, Recall # Z-...Read More

Company:Medtronic Emergency Response Systems, Inc., Date of Enforcement Report:12/27/2006 Class:ll PRODUCT LIFEPAK 20 automatic external defibrillator, Recall # Z-0295-2007 REASON LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power. CODE Devices with software version -028, -030, -032, and -038. RECALLING FIRM/MANUFACTURER Medtronic Emergency Response Systems, Inc., Redmond...Read More

Recipient: MRL Inc., a Welch Allyn Co..Product:Automatic external defibrillators Date:12/8/06 Failure to have production and process controls for automated processes, as required by 21 CFR 820.70(i). when computers or automated data processing systems are used as part of production or the quality system. A manufacturer is required to validate computer software for its intended use...Read More

Company:Data Innovations, Inc. Date of Enforcement Report:12/6/2006 Class:ll PRODUCT a) Roche Modular Drive (rchmdlri), analytical laboratory data interface, Recall # Z-0223-2007; b) Roche Cobas driver (rchcob6i), analytical laboratory data interface, Recall # Z-0224-2007 REASON Software of modular driver may incorrectly report patient results as Quality Control Results. CODE a) Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and...Read More

Company:AGFA Corp., Date of Enforcement Report:11/29/2006 Class:ll PRODUCT CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405), Recall # Z-0219-2007 REASON Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on...Read More

Company: Beckman Coulter Inc Date of Enforcement Report:11/29/2006 Class:ll PRODUCT Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1, Recall # Z-0197-2007 REASON Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube...Read More

Company:Data Innovations, Inc., Date of Enforcement Report:11/22/2006 Class:ll PRODUCT Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R), Recall # Z-0167-2007 REASON Patient results may be associated with an incorrect specimen. CODE Software Versions: 8:00, 8.01, 8.02, 8.03 or 8..04 RECALLING FIRM/MANUFACTURER Data Innovations, Inc., South...Read More

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Sherman Eagles, a Medtronic Standards representative and co-chair of the AAMI software committee, gave a presentation on changes and new developments in software standards at the Nov 2006 Advamed conference. This presentation is at the link provided. It addresses the withdrawal of ISO/IEC 60601-1-4 and the incorporation of Programmable Electronic Medical Systems (PEMS) into the...Read More

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CompanyGuidant Corporation Date of Enforcement Report:11/1/2006 Class:ll PRODUCT Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators, Recall # Z-0002-2007 REASON Final software load did not occur prior to shipment of select programmers. CODE Serial numbers: 051089, 051449, 055130, 056463,...Read More

/docs/FDAPortableInvasiveGlucoseMonitoring-DraftGuidance102406.pdfRead More

Company:AGFA Corp., Date of Enforcement Report:10/18/2006 Class:ll PRODUCT CR DX-S, Image Intensified Fluoroscopic X-ray system, Recall # Z-0031-2007 REASON Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss. CODE Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below. RECALLING FIRM/MANUFACTURER Recalling...Read More

Company: Hitachi Medical Systems America Inc. Date of Enforcement Report:10/18/2006 Class:ll PRODUCT MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J, Recall # Z-0029-2007 REASON Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol,...Read More

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A new work item proposal was approved to begin a draft Risk Management of IT networks incorporating medical devices. Formal work is planned to beginning in January 2007.Read More

Recipient: Patterson Technology Center Inc. Product:EagleSoft software Date:10/24/06 Failure to maintain procedures for receiving and evaluating complaints by a fomally designated unit; failure to establish and maintain adequate procedures for implementing corrective and preventive action; failure to establish and maintain adequate design control procedures to ensure design procedures address the planning, inputs, outputs, review, verification,...Read More

Recipient: Biolase Technology Inc.Product:Medical and dental lasers Date: 9/5/06 Design output procedures do not allow for an adequate evaluation of conformance to design input requirements as required by 21 CFR 820.30(d). Specifically, the software requirement input specifications for the Waterlase MD dental laser could not be individually verified and documented to show conformance to the...Read More

Company: GE OEC Medical Systems, Inc. Date of Enforcement Report:10/11/2006 Class:ll PRODUCT a) GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, Recall # Z-1301-06; b) GE OEC 9800 Fluoro C-Arm X-ray system, Recall # Z-1302-06; c) RUS Tool Version Software, Recall # Z-1303-06 REASON X-ray systems could provide output which exceeds the 20 R/minute...Read More

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Recipient: Terumo Cardiovascular Systems.Product:Advanced Perfusion System (APS-1) Date:8/31/06 Failure to file a report of corrections or removals as required by Subpart B of 21 CFR 806. For example, your firm failed to promptly report to the FDA, as required by 21 CFR.806.10, the field correction action number NFC 813720, an action performed by your firm...Read More

Company: Philips Medical Systems Date of Enforcement Report:9/20/2006 Class:ll PRODUCT IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A, Recall # Z-1487-06 REASON Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached . CODE M3001A options A01, A01C06, A01C12, and A01C18 with serial number prefix DE512 and MMS...Read More

Company:Beckman Coulter Inc., Brea, CA Date of Enforcement Report:9/13/2006 Class:ll PRODUCT FP1000 Cell Preparation System Part Number 624922, Recall # Z-1466-06 REASON During the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Cell Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack...Read More

Company:Bayer Healthcare, LLC Date of Enforcement Report:9/6/2006 Class:ll PRODUCT ADVIA 2120 systems –Automated Complete Blood Cell and Differential Cell Counter, Recall # Z-1376-06 REASON The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an abnormal baso...Read More

Company: BEckman Coulter Inc. Date of Enforcement Report:9/6/2006 Class:ll PRODUCT UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems, Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4, Recall # Z-1440-6 REASON Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly...Read More

Company:Alaris Products, FDA News FOR IMMEDIATE RELEASE P06-119 August 28, 2006 Media Inquiries: Catherine McDermott, 301-827-6242 Consumer Inquiries: 888-INFO-FDA United States Marshals Seize Defective Infusion Pumps Made by Alaris Products Pumps Can Deliver Excess Medication and Harm Patients At the request of the U.S. Food and Drug Administration (FDA), the U.S. District Court for the...Read More

Recipient: Vapotherm IncProduct:”Vapotherm 20001″ respiratory gas humidifier Date: 6/12/06 Failure to verify and validate corrective and preventive actions to ensure that the action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example, CAPA 05-032 includes a request to review cleaning protocols for improvement in existing cleaning...Read More

Company: Varian Medical Systems Date of Enforcement Report:8/23/2006 Class:ll PRODUCT a) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row, part number GM11005400, for the GammaMed model 12i radionuclide applicator system, Recall # Z-1398-06; b) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed...Read More

Recipient:Aksys Ltd..Product:Aksys PHD Personal Hemodialysis System Date: 6/806 Our records do not show that you obtained marketing clearance or approval before you began offering your device for sale with a modified treatment length. The device was cleared via a premarket notification (510(k)) _____, on _____, with a specified treatment length of _____ using a _____....Read More

Company: Edwards Lifesciences Llc, Date of Enforcement Report:8/23/2006 Class:ll PRODUCT Edwards Vigilance Monitors (Formerly Baxter Vigilance Monitors). Patient monitor which measures cardiac output. Models: VG, VGS, VGS1, VGS2, VG2, & IVM, Recall # Z-1310-06 REASON Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the...Read More

Recipient: Pointe Scientific Inc.Product:Hemoglobin A1c, Liquid Glucose Hexokinase, Liquid Alkaline Phosphatase, Liquid Auto Density Lipoprotein (Auto HDL) Cholesterol and other chemical analyzersr Date: 8/11/06 Failure to maintain procedures to ensure that the specified design requirements are met; failure to review all complaints to determine whether an investigation is necessary; failure to maintain procedures for implementing...Read More

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Company:Radiometer America Inc. Date of Enforcement Report:8/16/2006 Class:lI PRODUCT a) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series, Recall # Z-1317-06; b) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series, Recall # Z-1318-06 REASON Software defect. pO2 and pCO2 sample test results run on the firm’s ABL700/800 Series Blood Gas Analyzers...Read More

FDA’s Center for Biologics Evaluation and Research issued the following: “Compliance Program Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002” This guide mentions software and computer systems in one paragraph which is provided below: “Computers: The performance of computer software must be validated (if customized) or verified (if used “off-the-shelf”) for...Read More

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Company: Radiometer America, Inc, Date of Enforcement Report:8/16/2006 Class:lIl PRODUCT ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21, Recall # Z-1325-06 REASON ABL800 Series Blood Gas Analyzer became inoperable when the restore default setup button was touched.. CODE Software Versions 5.21 i.e. ABL8xx 754R00xx N0xx RECALLING FIRM/MANUFACTURER Recalling Firm: Radiometer America, Inc., Westlake,...Read More

Company:ABX Diagnostics Date of Enforcement Report:8/23/2006 Class:lll PRODUCT ABX Pentra 120, 120R, 120DX, automated hematology analyzer, Recall # Z-1334-06 REASON Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.. CODE All serial numbers, all software versions. RECALLING FIRM/MANUFACTURER Recalling Firm: ABX Diagnostics, Inc., Irvine,...Read More

Company: Immucor, Inc., Date of Enforcement Report:8/23/2006 Class:ll PRODUCT Galileo Automated Blood Bank Analyzer (in-vitro diagnosis testing of human blood using a microplate platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red cell antibodies and compatibility testing), Recall #B-1645-6 REASON Blood Bank Analyzer, with a software glitch, was distributed. CODE atalog...Read More

Recipient: Sonotech Inc.Product:Ultrabio Sterile ultrasound coupling gel Date:8/8/06 Failure to validate processes that cannot be fully verified by subsequent inspection and test; failure to establish and maintain procedures for finished device acceptance; failure to maintain a device master record that referred to the location of the packaging and labeling specifications; failure to conduct quality audits...Read More

Company: AGFA Corp., Date of Enforcement Report:8/23/2006 Class:lI PRODUCT Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators, Recall # Z-1375-06. REASON A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators. CODE...Read More

Company: Kensey Nash Corp., Date of Enforcement Report:8/9/2006 Class:ll PRODUCT TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach, Recall # Z-1305-06 REASON Alarm activation-A priming issue involving the flow control unit due to...Read More

FDA announced in the Federal Register (Docket No. 1992S–0251) a central Gateway/single point of entry for electronic submissions for device, drug and biologic applications. It is referred to as the Electronic Submission Gateway (ESG). The announcement describes three secure options for electronic submissions: “The FDA ESG offers two secure communication options for applicants that have...Read More

Company: AGFA Corp., Date of Enforcement Report:8/2/2006 Class:lIl PRODUCT IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images, Recall # Z-1256-06 REASON Possible corrupted image appearing after System Start. CODE All Impax 4.5 sites running Solaris 9 (Sun OS 5.9) that do not have Sun Patch ID 118305-08...Read More

Company: SCC Soft Computer, Date of Enforcement Report:8/2/2006 Class:lI PRODUCT SoftPath ASXII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinical documentation and data processing, Recall # Z-1243-06 REASON Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a...Read More

Company: Varian Medical Systems, Date of Enforcement Report:8/2/2006 Class:lI PRODUCT a) Gamma Win software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus radionuclide applicator system, for radiation therapy, Recall # Z-1268-06; b) Gamma Win software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus 3/24 radionuclide applicator system,...Read More