Company: Rocky Mountain Lions Eye BankProduct: Human corneas, sclera and whole eye globes Date: 1/26/04 Paragraph 12 of the Biohazardous Waste Disposal procedure includes the provision that the Quality Assurance (QA) staff will review and verify the documentation of destroyed tissue on the Destruction Log is consistent with the record entry in the chart and...Read More

Company: Urologix, Inc., Date of Enforcement Report: 1/21/04 Class: II PRODUCT Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperplasia). The Prostatron utilizes a transurethral microwave antenna, with simultaneous urethral cooling, to heat the prostate. This heating process is regulated through feedback from...Read More

Company: General Electric Medical Systems Information TechnologyDate of Enforcement Report: 1/21/04 Class: II PRODUCT Solar 9500 Information Monitor. Recall # Z-0250-04. REASON Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first. CODE Software version 3A. RECALLING FIRM/MANUFACTURER General Electric Medical Systems Information Technology, Milwaukee,...Read More

Company: Medtronic MiniMedDate of Enforcement Report: 1/21/04 Class: III PRODUCT Medtronic MiniMed. Model 7311 Solutions Pumps and Meters Software. Recall # Z-0265-04. REASON Accessory software fails to report certain reports following download of data from 712 pump. CODE Version 5.0A. RECALLING FIRM/MANUFACTURER Medtronic MiniMed, Northridge, CA, by visit or FedEx software on CD-rom beginning on...Read More

Company: Misys Healthcare Systems.Date of Enforcement Report: 1/21/04 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-0235-04. REASON Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by facsimile...Read More

Company: Roche Diagnostics Corp.Date of Enforcement Report: 1/21/04 Class: II PRODUCT a) Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R. Recall # Z-0326-04; b) Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R. Recall # Z-0327-04; Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and...Read More

Company: James Howe M.D. – University of Vermont College of MedicineProduct: Investigational device Date: 1/16/04 The x-rays and radiology report for patient [redacted] 24-month visit in 2002 were not included in the subject’s file. The patient’s Radiographic Evaluation form you signed on September 27, 2002, shortly after [redacted] 24-month visit was scheduled to take place,...Read More

Company:Minolta Corp.Date of Enforcement Report: 1/14/04 Class: II PRODUCT a) Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger,...Read More

Company: Information Data ManagementDate of Enforcement Report: 1/9/04 DATE RECALL INITIATED: January 9, 2004 PRODUCT / VERSIONS: IDM Surround System, Software versions 3.4, 3.5, and 3.6 REASON: IDM’s Surround System fails to recognize duplicate batches when used in conjunction with the Abbott PPC (Parallel Processing Center) and the TPC (Total Process Control) mode is utilized....Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 12/24/03 Class: II PRODUCT Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata Upgrade, Syngo Symphony, Syngo Symphony Q, and Syngo Symphony Upgrade. Model numbers 4772906, 7106995, 7104693, 5751438, 7106714, 7104719, 7106425, 7104594, 4772971, and...Read More

Company: Eldon Biologicals A/S.Product: Medical device Date: 12/23/03 Microsoft 2000 Excel spreadsheet software used manufacturing has not been validated for the purpose of generating a worksheet for formulation of reagents. No documentation was found to establish or verify corrections made to the program. Failure to validate computer software for its intended use according to an...Read More

Company: IND Diagnostic Inc.Product: Medical device Date: 12/23/03 Failure to establish and maintain procedures to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results as required by 21 CFR 820.72 (a). Issuer: Center for...Read More

Company: Varian Brachytherary VirginiaDate of Enforcement Report: 12/17/03 Class: II PRODUCT BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Recall # Z-0176-04. REASON The manufacturer’s instructions for using radiation treatment software may cause healthcare practitioner to administer an incorrect treatment to...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 12/10/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0151-04. REASON Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modfy/Reject prompt will cause the order not to be processed by the system. CODE Versions 5.2, 5.23, 5.3 up to...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 12/10/03 Class: I PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-0007-04. REASON Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient’s chart without review. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by facsimile on August...Read More

Company: Medron Inc.Product: Various catheters Date: 12/3/03 We are in receipt of your correspondence dated June 6, 2003 in response to the FD-483 issued at the conclusion of the inspection. Your response is inadequate in that all numbered items listed above were not addressed. However, we acknowledge that you have implemented some corrective action with...Read More

Company: Biotronik, Inc.Date of Enforcement Report: 11/26/03 Class: II PRODUCT a) Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. Recall # Z-0076-04; b) Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. Recall # Z-0077-04. REASON Potential for early depletion of Implantable Cardioverter Defibrillator battery. CODE a) Serial Numbers: 7811xxxx;...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 11/19/03 Class: II PRODUCT AEROSET System Software, Catalog 2-95068-01 version 1.02ER000 and Catalog 2-95175-01 AEROSET System Software, version 1.02ER000 Upgrade Kit. Recall # Z-0091-04. REASON Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples. CODE Version 1.02ER000 and...Read More

Company: General Electric Medical Systems Information Technology,Date of Enforcement Report: 11/19/03 Class: II PRODUCT Solar 8000M Patient Monitor. Recall # Z-0092-04. REASON Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display,...Read More

Company: Veterans Health Administration Office of InformationDate of Enforcement Report: 11/19/03 Class: II PRODUCT VistA Blood Bank Software. Recall # B-0301-4. REASON Blood establishment computer software that could allow the release of unsuitable blood products was distributed. CODE Version number 5.2, software patch LR*5.2*301. RECALLING FIRM/MANUFACTURER Recalling Firm: Veterans Health Administration Office of Information, Hines,...Read More

Company: Central Texas Regional Blood and Tissue CenterProduct: Blood products Date: 11/7/03 Specifically, one donor tested Nucleic Acid Test (NAT) HIV positive on a unit donated 4/4/2002. The donor donated a Whole Blood unit on 4/16/2002. The testing laboratory requested the Fresh Frozen Plasma (FFP) to be tested from the 4/16/2002 donation and all tests...Read More

Company: Bayer Corp.Date of Enforcement Report: 11/5/03 Class: II PRODUCT Bayer Rapidpoint 405 Blood Gas Analyzer. Recall # Z-0066-04. REASON Potential for bias shift in p02 values due to air bubble in sample path. CODE Software Versions below 3.1. RECALLING FIRM/MANUFACTURER Bayer Corp., Medfield, MA, by telephone and letter dated September 26, 2003. Firm initiated...Read More

Company: Olympus America Inc.Date of Enforcement Report: 10/22/03 Class: II PRODUCT Olympus ImageManager Software, Common name: Medical image storage device {NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking.) Recall # Z-0047-04. REASON Software malfunction; potential for simultaneous cross-linking of...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 10/22/03 Class: II PRODUCT Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156. Recall # Z-0012-04. REASON Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the RI reagent is depleted. CODE All units with current software...Read More

Company: Tri-State Analytical Laboratory LLCProduct: Analyzed drug products Date: 10/22/03 Inadequate Standard Operating Procedures that are not always available, lack appropriate details, or contain contradictory information. For example, the written procedure for method validation lacks detailed instructions and acceptance criteria for each test and conflicts with the protocol. Additionally, some software application and microbiology lab...Read More

Company: Medi-Stat Inc.Product: Pulse oximeter sensors Date: 10/17/03 The Device Master Record you submitted is inadequate. A Device Master Record is specific for each device and must include or refer to the location of the following information: a.) device specifications, including appropriate drawings, composition, formulation, component specifications and software specifications; b.) production process specifications including...Read More

Company: DPC CirrusDate of Enforcement Report: 10/15/03 Class: III PRODUCT Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software. Recall # Z-1138-03. REASON Version 2.6 software was released however, it will not properly handle adjustment slopes. CODE All units. RECALLING FIRM/MANUFACTURER DPC Cirrus, Flanders, NJ, by Recall Technical...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 10/8/03 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-1240-03. REASON Software Defect. CODE Verison 5.3 through 5.3.2. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on July 23, 2003. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 466. DISTRIBUTION Nationwide.Read More

Company: Nutra Med Inc.Product: Over-the-counter and prescription drug products Date: 10/2/03 Failure to maintain records of the inspections of automatic, mechanical or electronic equipment, including computers or related systems. [211.68(a)]. For example, equipment qualification was not adequate for the following drug manufacturing equipment: Double Cone Blender (_____ kg.), Fitzpatrick Fitzmill Comminuting Machine, Coating Pans, Kent...Read More

Company: Consolidated Machine Corp.Product: Steam sterilizers Date: 9/24/03 Our inspection confirmed that in 1994 your firm introduced the Mark V microprocessor that is marketed as an attachment to all of your approximately fourteen steam sterilizers. This microprocessor is software driven and controls the time and temperature of the sterilization cycles. This microprocessor addition constitutes a...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 9/24/03 Class: II PRODUCT a) Gyroscan ACS-NT with software versions R6x, R7x, R8x. Recall # Z-1227-03; b) Gyroscan NT-Intera. Recall # Z-1228-03; c) Gyroscan Intera 1.0T & 1.5T. Recall # Z-1229-03. REASON Patient burns from cables near or in contact with the patient during use. CODE a) 6808,...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 9/24/03 Class: II PRODUCT HeartStart XL Defibrillator Monitor. Model M4735A. Recall # Z-1226-03.M CODE Units with software versions A.02.00 or greater. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA, by letter on September 2, 2003. Firm initiated recall is ongoing. REASON Instructions for use include additional information on configuration...Read More

Company: Con-Cise Lens Co.Product: Rigid gas permeable contact lenses Date: 9/19/03 Failure to perform and document validation of computer software that is used as part of production [21 CFR 820.70(i)]. Specifically, the software used to control the DAC DLL Series 3…has not been validated. We note that seven items on the Form FDA 483 issued...Read More

Company: Harvard Clinical TechnologyDate of Enforcement Report: 9/17/03 Class: II PRODUCT Harvard 2, Dual Infusion Pump (P/N 2002-001). Recall # Z-1208-03. REASON Under specific sequence conditions, the unit may appear to be infusing, but is not. CODE Software versions V1.2R or earlier. RECALLING FIRM/MANUFACTURER Harvard Clinical Technology, South Natick, MA, by letter on August 11,...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 9/17/03 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-1220-03. REASON Software Design Defect. Under certain conditions, results are removed. CODE Version 3.x. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ by facsimile on July 24, 2003. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 9/17/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1217-03. REASON Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported. CODE Version 5.2 through 5.3.2 using LabAccess Results. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on...Read More

Company: Philips Medical Systems.Date of Enforcement Report: 9/17/03 Class: II PRODUCT Easy Access PACS System with software. Recall # Z-471-3. REASON Potential display of an incorrect body part description on patient images. CODE Software Release 5, 6.2, or 7.2. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Bothell, WA, by letter on February 13, 2002. Firm initiated recall...Read More

Company: Laborde Diagnostics at South CollegeProduct: Mammography facility Date: 9/12/03 The specific deficiency noted above appeared on the MQSA Post Inspection Report, which was given to your facility by the state inspector along with instructions on how to respond to this finding. Your facility responded to this same noncompliance issue in a letter dated September...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 9/10/03 Class: II PRODUCT Abbott Aeroset System list number 9D05-01. Recall # Z-1142-03. REASON ICT assays run using a manual dilution will not be calculated correctly by the software. CODE All units. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by letter dated December 29, 2000. Firm initiated recall...Read More

Company: ABX Diagnostics, Inc.Date of Enforcement Report: 9/10/03 Class: II PRODUCT ABX Diagnostices Pentra 60C+ Hematology Analyzer. Recall # Z-1149-03. REASON Instrument fails to obtain correct patient information/results due to malfunction of the equipment’s sample door. CODE Software versions of up to 1.7. RECALLING FIRM/MANUFACTURER ABX Diagnostics, Inc., Irvine, CA, by letter on June 5,...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 9/10/03 Class: II PRODUCT Access Immunoassay System Technical Update 03.1, Part number 387851. Recall # Z-1148-03. CODE Software version 3.29. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA., by telephone between June 18, 2003 and July 3, 2003. Firm initiated recall is ongoing. REASON Defective software media distributed with...Read More

Company: Edrugnet.comProduct:”Roaccutane Isotretinoin 10 mg capsules” Date: 9/9/03 Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part, “Accutane must not be used by females who are pregnant…must be...Read More

Company: Today’s BusinessProduct:”Isotrex Isotretinoina Gel 0.05%” Date: 9/9/03 “Accutane must not be used by females who are pregnant…must be prescribed under the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription,” (meaning special training has been given to the prescribing licensed practitioner and the patient) “and no...Read More

Company: Medicapharma.comProduct: “Roaccutane Isotretinoin 10 mg tablet” Date: 9/9/03 Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part. “Accutane must not be used by females who are pregnant…must...Read More

Company: Medicine-MexicoProduct: “Isotrex Isotretinoina Gel 0.05%” Date: 9/9/03 “Accutane must not be used by females who are pregnant…must be prescribed under the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription,” (meaning special training has been given to the prescribing licensed practitioner and the patient) “and no...Read More

Company: Medsmex.comProduct: “Isotrex Isotretinoina Gel 0.05% Date: 9/9/03 Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part, “Accutane must not be used by females who are pregnant…must be...Read More

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Company: Misys Healthcare SystemsDate of Enforcement Report: 8/27/03 Class: II PRODUCT Misys Laboratory System versions 5.3 up to 5.3.2 with Lab Access Results Workstation. Recall # Z-1093-03. REASON Software defect. When Quality Assurance failure warnings are missing from a patient’s report abnormal results could be used for diagnosis or treatment. CODE Versions 5.3 up to...Read More

Company: Olympus America, IncDate of Enforcement Report: 8/27/03 Class: II PRODUCT Olympus Image Manager Software. Recall # Z-1126-03. REASON Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system. CODE Versions 6.0 through 6.4. RECALLING FIRM/MANUFACTURER Olympus America, Inc., Melville, NY, by letters, dated...Read More

Company: Siemens Medical Solutions USA, IncDate of Enforcement Report: 8/27/03 Class: II PRODUCT a) MR Systems. Recall # Z-1087-03; b) Leonardo Workstations with software version 2022A/B, 2003A. Recall # Z-1088-03; c) Leonardo Workstations with software versions prior to 2022A. Recall # Z-1089-03. REASON Software problem. This error may cause the loss of peripheral image information...Read More