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

Company: Shimadzu Medical SystemsDate of Enforcement Report: 9/7/05 Class:II PRODUCT C-Vision Angiographic X-Ray System, Model IVS-100, Recall # Z-1420-05 REASON Fluro exposure stuck open, will not terminate. CODE Software versions before 3.0 RECALLING FIRM/MANUFACTURER Recalling Firm: Shimadzu Medical Systems, Torrance, CA, by letter in April 2002. Manufacturer: Shimadzu Corporation, Kyoto, Japan. Firm initiated recall is...Read More

Company: Biosound Esaote, IncDate of Enforcement Report: 9/7/05 Class:II PRODUCT a) MyLab30CV Ultrasound Imaging System; model 9807300000, Recall # Z-1401-05; b) MyLab30CV Ultrasound Imaging System; model 9807300001, Recall # Z-1402-05; c) MyLab25 Ultrasound Imaging System; model 9807300002, Recall # Z-1403-05 REASON Data maybe corrupted upon re-opening archived files. CODE a) All units using software version...Read More

Recipient: Tepnel Diagnostics Inc.Product:Elucigene genetic assays Date: 8/26/05 FDA District: New England District OfficeBased on information on your website, these devices do not adhere to the restrictions on the sale, distribution, and use of ASRs. Your website makes specific analytical and performance claims such as that your devices can detect multiple mutations per device and...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 8/24/05 Class: II PRODUCT Cytomics FC500 MPL with MXP Software, Recall # Z-1377-05 REASON Software anomaly. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results. CODE Versions...Read More

Company: CepheidDate of Enforcement Report: 8/24/05 Class: II PRODUCT SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler, Recall # Z-1378-05 REASON A problem in the software has the potential to be associated with the incorrect reporting of sample results. CODE All units with software code version numbers: PN950-0101, Rev 1.7...Read More

Company: Konica Medical Imaging, Inc,Date of Enforcement Report: 8/24/05 Class: III PRODUCT Regius-IM, The Regius Image Manager for Centralized workflow and improved image quality software, Recall # Z-1391-05 REASON One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three...Read More

Company: Datascope CorpDate of Enforcement Report: 8/17/05 Class: II PRODUCT Panorama Patient Monitoring Network Cardiac Arrhythmia Monitor, Recall # Z-1104-05 REASON Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages. CODE All units on the market RECALLING FIRM Datascope Corp,...Read More

Recipient: Boston Scientific Corp.Product:Vaxcel Low Profile Infusion Ports, Taxus paclitaxel drug eluting stents and Symmetry balloon dilation catheters Date: 8/10/05 Failure to analyze processes, work operations and other sources of quality data to identify existing and potential causes of non-conforming product as required by 21 CFR 820.100(a)(1). For example, we observed the release and actual...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 8/10/05 Class: II PRODUCT Misys Laboratory, Version 6.1, Recall # B-1566-5 REASON Defects in the design of software could result in loss of patient information. CODE Version 6.1 RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by facsimile and e-mail dated May 20, 2005. Firm initiated recall is ongoing....Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 8/10/05 Class: II PRODUCT StemCXP Software, version 1.0 for Cytomics FC 500, Recall # B-1738-5 REASON StemCXP Software, which had a glitch or defect, was distributed. CODE Version 1.0 RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter dated February 24, 2005. Manufacturer: Beckman Coulter, Inc.,...Read More

Company: Baxter Healthcare Corporation,Date of Enforcement Report: 7/27/05 Class: I PRODUCT a) Baxter Colleague Single Channel Volumetric Infusion Pumps, product codes: 2M8151, 2M8151R, 2M8161, 2M8161R, Recall # Z-1022-05; b) Baxter Colleague triple Channel Volumetric Infusion Pumps, product codes: 2M8153, 2M8153R, 2M8163, 2M8163R, Recall # Z-1023-05 REASON The pumps may experience inadvertent power off, external communications...Read More

Company: Beckman Coulter Inc,Date of Enforcement Report: 7/27/05 Class: II PRODUCT Beckman Coulter 1500 Series Hematology Automation System; Part Number: 988609 (LH Basic Unit) 988610 (LH Connection Unit), Recall # Z-1041-05 REASON Risk of injury to workers due to mechanical or electrical hazards. Corrective action will include shields, covers, software interlocks, a spill tray, and...Read More

Company: Toshiba American Med Systems, IncDate of Enforcement Report: 7/20/05 Class: II PRODUCT Magnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart Vantagae, Recall # Z-0986-05 REASON Patient information A is displayed with images of patient B. CODE All codes RECALLING FIRM Recalling Firm: Toshiba American Med...Read More

Recipient: Uroplasty Inc.Product: Investigational devices Date: 7/19/05 The inspectional report notes that review of subject records across five (5) investigational sites revealed that study procedures were initiated on 30 subjects prior to obtaining the informed consent of these individuals as required by the regulations at 21 CFR Part 50. The inspectional report further notes that...Read More

Company: Baxter Healthcare Renal Div,Date of Enforcement Report: 7/13/05 Class: III PRODUCT Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R, Recall # Z-0947-05 REASON The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system. CODE All serial numbers with software version 4.0 or below RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare...Read More

Recipient: Hitachi Medical Systems America Inc.Product: Magnetic Resonance Imaging Systems Date: 7/13/05 On April 20, 2004, your firm issued a Software Release Bulletin instructing the service representatives to install a software upgrade to all Altaire/AIRIS MRI systems. This upgrade fixed the problem of images from one patient’s study being co-mingled with another patient’s study. Your...Read More

Company: Philips Ultrasound, Inc.,Date of Enforcement Report: 7/6/05 Class: II PRODUCT Envisor, M2540 Diagnostic Ultrasound System, Part numbers: 453561193003, SW C.O.O. Recall # Z-0923-05 REASON A defect in the software allows incorrect measurement results to be entered into the system’s built-in report. CODE Serial numbers(domestic) 20505841, 20505867, 20505884, 20505885, 20505886, 20505890, 20505898, 20505907, 20505908, 20505913,...Read More

Company: Philips Medical Systems North America CoDate of Enforcement Report: 7/6/05 Class: II PRODUCT View Forum 2003 software, SW 3.4L1, Recall # Z-0896-05 REASON Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10. CODE The firm utilizes site numbers: 534544,...Read More

Company: Misys Healthcare Systems,Date of Enforcement Report: 7/6/05 Class: II PRODUCT Misys Laboratory with Lab Access Results application for versions 5.3 and later. Recall # Z-0938-05 REASON Software anomaly may rarely allow modification of previously reported specimen results. CODE Versions 5.3 and later RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on May 13,...Read More

Recipient:Con-Med Corp.Product: Irrigation pumps, hand pieces and surgical drills Date: 6/29/05 Software flags were added to rechargeable batteries after complaints were received referencing the battery’s depletion during surgery. No verification or validation of this corrective action was conducted. FDA District: Florida District OfficeRead More

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Company: Hitachi Medical Systems America Inc.Date of Enforcement Report: 6/22/05 Class: II PRODUCT a) Hitachi Altaire Magnetic Resonance Imaging Device. Recall # Z-0888-05; b) Hitachi AIRIS II Magnetic Resonance Imaging Device. Recall # Z-0889-05; REASON Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder. c) Hitachi...Read More

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Recipient: Millennium Dental Technologies IncProduct: Medical devices Date: 6/7/05 Our inspection found the following device QSR deficiencies Software used as part of the quality system has not been validated for its intended use according to an established protocol. Specifically, you are using a software system for your procedures that allows procedures to have inconsistent effective,...Read More

Recipient: Robert Hostoffer D.O.-Allergy and Immunology AssociatesProduct: Investigational biologics product Date: 6/6/05 You failed to collect the paper diary or electronic diary data as required by the protocol. The protocol stated that the paper diary was to be reviewed during the subject’s periodic visits with the clinical investigator (every 3-4 weeks) and that the electronic...Read More

Recipient: C & M Oxyfill LLC.Product: Compressed Oxygen USP Date: 5/26/05 Failure to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment according to a written program designed to assure proper performance [21 CFR 211.68(a)]. Specifically, your firm has not performed any equipment qualification on the “mobile” cryogenic pumping system which transfills your Compressed...Read More

Recipient: BioImageneProduct: PATHIAM software Date: 5/25/05 According to your website, PATHIAM is “a hardware-independent, Web-enabled software allowing pathologists to view and analyze immunohistochemically-stained (IHC-stained) slides from any computer via the Internet.” PATHIAM is a device as that term is defined in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S .C. 321(h))...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 5/25/05 Class: II PRODUCT Philips Medical HeartStart MRx Monitor/Defibrillator, Model: M3535A, M3536A. Recall # Z-0848-05. REASON The device may disarm and not deliver shock when performing a Synchronized Cardioversion. CODE Software Versions A.03.00 or lower and B.04.00 and lower. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA, by letter...Read More

The EU issued proposed new text for the Medical Device Directive (MDD). The document with highlighted revisions, additions, and deletions is at the link provided. The proposed changes include several additions to more explicity address software. These include adding: the word “software” into the definition of a medical device in section 2(a) Annex I 12.1b...Read More

The EU issued a proposal to modify the MDD. This proposal expresses several suggestions related to software. The full text is at the link provided. EU proposal for revision of MDDRead More

Company: Diasorin Inc.Date of Enforcement Report: 5/18/05 Class: III PRODUCT Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin Anafluor Indirect Fluorescent Antibody Test. Recall # Z-0807-05. REASON A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are...Read More

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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 5/11/05 Class: II PRODUCT Axiom Artis X-Ray System using software version VB11D or VB20B. Recall # Z-0796-05. CODE Model numbers 5904433, 5904441, 5904466, 7007755, 7008605, 7412807, 7413078, 7555365, 7555373, 7727717, and 7728350. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated...Read More

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Recipient: Electrologic of America Inc.Product: Electrical muscle stimulator stationary bicycles Date: 5/9/05 Failure to verify, validate and create a design history file when design changes were made to the StimMaster electrical muscle stimulation stationary bicycle [21 CFR 820.30(i) and (j)]. Engineering Change Notice, dated 11/1/02, states that four inches were removed from the front of...Read More

Recipient: Philips Medizin Systeme GmbhProduct: IntelliView patient bedside monitors Date: 5/6/05 CAPA investigation 4921 for complaints M2003-009925 and M2003-010130 received from the same hospital regarding a failure in the arrhythmia analysis software was not further investigated to determine whether similar defects in heart rate monitoring were reported by other facilities. Documentation shows the hazard/ risk...Read More

Company: Cerner CorporationDate of Enforcement Report: 5/4/05 Class: II PRODUCT HNA Classic 306 Patient Manager Blood Bank Software. Recall # B-0843-5. REASON Defects in the design of blood bank software could result in loss of patient antibody information. CODE Revision 159 and higher. RECALLING FIRM/MANUFACTURER Cerner Corporation, Kansas City, MO, by telephone calls beginning on...Read More

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Recipient: Pace Tech Inc.Product: Stationary and portable patient monitors Date: 4/29/05 Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures as required by 21 CFR 820 .75(a). Your firm fails to conduct...Read More

Recipient: Inoveon Corp.Product: Diabetic Retinopathy 3DT System Date: 4/27/05 Failure to establish and maintain adequate procedures for validating the device design to ensure that the device conforms to user needs and intended uses and include risk analysis, as required by 21 CFR 820.30(g) [FDA 483, Item 15]. For example, a formal risk analysis of the...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/27/05 Class: III PRODUCT Version 7 software for wash program on Bio Tek Automated Microplate Washer Model Elx50 which performs the washing steps for various programmed mictotiter plate assays. Recall # Z-0703-05. REASON When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/27/05 Class: III PRODUCT Version 12 software program written for the Bio- Tek ELx800 automated microtiter plate reader with use of PRO- Trac Tacrolimus ELISA kit. Recall # Z-0702-05. REASON The software program written for use in the automated microtiter plate reader (Bio- Tek ELx800) for use with the...Read More