Recipient:BTI Filtration Product: mixed bed deionization (DI) tanks and carbon tanks that are used to provide treated water to dilute dialysate for use in hemodialysis. Date:2/27/2007 Failure to ensure the device master record includes or refers to the location of the device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications, as required...Read More

Recipient:Seryx, lnc Product: Signature Genetics software program Date:2/22/2007 This letter is in response to the Food and Drug Administration’s (FDA’s) review of your web site www.seryx.com, and the information you provided to The Office oft Vitro Diagnostic Devices (OIVD) in FDA’s Center for Devices and Radiological Health in a telephone conference on May 23, 2006...Read More

Company:GE OEC Medical Systems,Inc Date of Enforcement Report:4/6/2007 Class:ll PRODUCT InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body), Recall # Z-0704-2007 REASON Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software. CODE InstaTrak 3500 Plus...Read More

Company:Boston Scientific Corp. Date of Enforcement Report:4/6/2007 Class:ll PRODUCT a) Product Description: HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system), Recall # Z-0687-2007; b) HTA Console System, 230 Volt, English, Product Number: 560010 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system), Recall #...Read More

Company:Siemens Medical Solutions Date of Enforcement Report:4/6/2007 Class:ll PRODUCT Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system, Recall # Z-0652-2007 REASON The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due...Read More

Company:bioMerieux, Inc., Date of Enforcement Report:3/28/2007 Class:ll PRODUCT BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, Recall # Z-0644-2007 REASON Bottle data is not sent to BacT/ALERT 3D instrument. CODE All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software). RECALLING FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC, by letter on December...Read More

/Docs/GE-ConsentDecree-Customer_Letter_1-15-07.pdfRead More

IEC 62A and ISO 210 balloting is complete and both approved the work item to initiate project number IEC 80002 Medical device software – Guidance on the application of ISO 14971 to medical device software. The first working group meeting will be in May in Germany. Depending on the direction this work takes it could...Read More

Company:Stentor Inc Date of Enforcement Report:3/21/2007 Class:ll PRODUCT The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data throughout a clinical environment, Recall # Z-0616-2007 REASON A defect may cause patient image orientation markers to be incorrectly labeled on...Read More

/docs/JMurrayPresentation-softwarecompliancescienceMarch2007.pdfRead More

Company:Beckman Coulter, Inc. Date of Enforcement Report:3/14/2007 Class:ll PRODUCT Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5), Recall # Z-0566-2007 REASON There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the...Read More

Company:Siemens Medical Solutions USA, Inc., Date of Enforcement Report:2/28/2007 Class:ll PRODUCT a) Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; part number 08717741, Recall # Z-0548-2007; b) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System with a Pinhole Collimator, Recall # Z-0549-2007 REASON Symbia systems, running...Read More

Company:Terumo Advanced Perfusion System 1 Date of Enforcement Report:2/7/2007 Class:ll PRODUCT Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046, Recall # Z-0381-2007 REASON Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and...Read More

Company:Cyberonics, Incl Date of Enforcement Report:1/31/2007 Class:ll PRODUCT a) Cyberonics VNS Therapy System, Model 250-‘HAND HELD’ programming software v6.1, v6.1.7, v7.0 and v7.1.3, Recall # Z-0341-2007; b) Handhelds-Cyberonics VNS Therapy System, Model 2500-‘Handhelds’ preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3, Recall # Z-0342-2007 REASON During programming, pulse generator may be inadvertently set to...Read More

Company:GE Healthcare Integrated IT Solution Date of Enforcement Report:1/31/2007 Class:ll PRODUCT GE Centricity PACS RA 1000 Workstation; for diagnostic image analysis; Software versions 2.1.XX. and 3.0.XX. used in combination with the GE Senographe 2000D, Senographe DS or Senographe Essential, Recall # Z-0373-2007 REASON The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display...Read More

/docs/SCPRed/SoftwareCPR-Newsletter0107.pdfRead More

Company:Beckman Coulter, Inc. Date of Enforcement Report:1/10/2007 Class:ll PRODUCT Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers, Recall # Z-0471-2007 REASON The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may...Read More

Company:Terumo Cardiovascular Systems Corp Date of Enforcement Report:1/5/2007 Class:ll PRODUCT a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763, Recall # Z-0314-2007; b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within...Read More

Company:Beckman Coulter Inc., Date of Enforcement Report:1/4/2007 Class:ll PRODUCT LFC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit, Recall # Z-0317-2007 REASON The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog...Read More

/docs/FDAComplementaryandAlternativeMedicineProductsDraft2006.pdfRead More

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

/docs/CBERaccessoriesIVD0506.pdfRead More

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

/docs/IVDDFDARegulationofSoftwarePresentation1106.pdfRead More

/Docs/FDAJMurray-SoftwareDesignControls041006.pdfRead More

/docs/Part11AdvaMednov82006finalA.pdfRead More

/Docs/GERecallLetter9800_8800_6800Nov2007.pdfRead 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

/Docs/GEadvisory_notice_OEC_InstaTRAK_3500_15037.pdfRead More

/docs/SCPRed/SoftwareCPR-Newsletter0906.pdfRead More

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