Company: Baxter Healthcare Renal DivDate of Enforcement Report: 5/19/04 Class: II PRODUCT a) Baxter Renal Software Suite (Renal Link and PD Link). Recall # Z-0901-04; b) Renalsoft software system. Recall # Z-0902-04. REASON There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 5/19/04 Class: II PRODUCT Coulter LH750 Hematology Analyzer. Part Number 6605632. Recall # Z-0905-04. REASON If a customer enters a dilution factor for Sample B prior to the results from Sample A being transferred to the workstation, the predilute multiplication factor will be applied erroneously to the Sample...Read More

Company: Respironics California IncDate of Enforcement Report: 5/19/04 Class: II PRODUCT Esprit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics. Recall # Z-0903-04. CODE All codes. RECALLING FIRM/MANUFACTURER Respironics California Inc., Carlsbad, CA, by technician visit on or about June 1, 2001. Firm initiated recall is complete. REASON Ventilator would spontaneously suspend ventilatory support to...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 5/19/04 Class: II PRODUCT UniCel Dxl 800 Access Immunoassay System, P/N 973100. Recall # Z-0904-04. REASON Software coding error may cause a fatal error message. CODE All software versions prior to version 1.4. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letters on March 29, 2004. Firm initiated...Read More

Company: ADAC Laboratories, MadisonDate of Enforcement Report: 5/19/04 Class: II PRODUCT a) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-9052A-ENG. Recall # Z-0911-04; b) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-0613C-ENG. Recall # Z-0912-04; c) Pinnacle3 Radiation Therapy Planning System, Part Number 9104-2011A Rev. A. Recall # Z-0913-04; d) Pinnacle3 Radiation Therapy Planning System,...Read More

Company: Toshiba American Med Sys IncDate of Enforcement Report: 5/12/04 Class: III PRODUCT Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems. Recall # Z-0937-04. REASON Software anomaly. The region of the...Read More

Company: Efoora Inc. dba Virotek LLCProduct: Lancets and inoculating loops Date: 5/12/04 Your firm failed to validate computer software used as part of the quality system as required by 21 CFR 820.70(i). For example, your firm has no documented validation activities and results for the _____ electronic data management system. Your firm failed to establish...Read More

Company: Hudson Respiratory Care Inc.Date of Enforcement Report: 5/12/04 Class: II PRODUCT Concha IV Plus Heated Humidifier. Recall # Z-0929-04. REASON Software malfunction. CODE All products manufactured with software 11738 -rev.03, Version V13.6, 252 A. This represents all units currently in the field. RECALLING FIRM/MANUFACTURER Hudson Respiratory Care Inc, Temecula , CA , by visit...Read More

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Date Recall Initiated: May 5, 2004 Product: Tecan Clinical Workstation configured with the Roche Diagnostics Amplicor CT/NG Analyzer Use: The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia and gonorrhea. Recalling Firm: Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46256-1025 Reason for Recall: A software error...Read More

Medical Device RecallsClass 1 Recall: Roche Diagnostics COBAS GUI Software for the Tecan Clinical Workstation Date Recall Initiated: May 5, 2004 Product: COBAS GUI Software Interface between the Tecan Clinical Workstation and the COBAS Amplicor Analyzer. Use: The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia and...Read More

Medical Device RecallsClass 1 Recall: Tecan Clinical Workstation with RoboNet Software Date Recall Initiated: May 3, 2004 Product: Tecan Clinical Workstation configured with the RoboNet Software. Use: The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia, gonorrhea and other tests. An operator controls the Tecan Clinical Workstation...Read More

Company: Hunterdon Medical CenterProduct: Biologics/Blood Date: 5/3/04 Failure to maintain accurate records which identify unsuitable donors so that products from such individuals will not be distributed, as required by 21 CFR 606.160(e). For example, in June 2003, it was discovered that all donor cards from the year 2000 were inadvertently destroyed. Without the original donor...Read More

This is one of the FDA recognized software standards.Read More

Company: Gyrus Medical, IncDate of Enforcement Report: 4/28/04 Class: II PRODUCT Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications. Recall # Z-0841-04. REASON The generator may malfunction when used in close proximity to a monopolar generator. CODE Model 744000....Read More

Company: Tri-Med Laboratories IncProduct: “PSE Carbinoxamine DM Syrup,” “Carbodex DM Syrup,” “Ronddamine DM Syrup” and other drugs Date: 4/28/04 Your investigation report for failing Pediahist lot F312 indicates that the batch was formulated superpotent because the manufacturing order sheet was reproduced from another product format on a computer, hence the incorrect amounts of ingredients were...Read More

Company: Abbott Laboratories, Inc.Date of Enforcement Report: 4/28/04 Class: II PRODUCT ARCHTECT System RS-232 Manual, product list number 06F71- 04, for the ARCHITECT i2000 Processing Module and the ARCHITECT C8000 Processing Module. Recall # Z-0818-04. REASON When using a LIS the software system will send up a test result of up to 20 characters although...Read More

Company: Positron CorpProduct: “POSICAM HZ,” “POSICAM HZL,” “mPower PET” and other Positron Emission Tomography diagnostic scanners Date: 4/26/04 The above-referenced service reports indicated that an upgrade was needed. There are no records attached or referenced in these service reports or clear descriptions to explain if the upgrade was due to a hardware design problem, a...Read More

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Company: Medex, Inc.Date of Enforcement Report: 4/21/04 Class: III PRODUCT Medex 3000 Series Syringe Infusion Pumps. Recall # Z-0813-04. CODE Model numbers: 3010 (General use pump for use with 3cc to 60cc syringes, 3010a (Pump for use with 1 cc to 60cc syringes), 3010aE (Use with 1cc to 60cc syringes in UK), 3010aVX (Evaluation pump...Read More

Company: Spencer Technologies, Inc.Date of Enforcement Report: 4/21/04 Class: II PRODUCT Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the same hardware and software – the change from TCD 100M to PMD 100 is a marketing change)....Read More

Company: Surgilight IncProduct: Optivision Laser System Date: 4/20/04 Validation of Borland Compiler is incomplete because software used to control passwords was not addressed (FDA 483, Item #3) Complaint #17 dated December 17, 2001, references software locked up due to possible computer time and/or patient file recreation. Failure not determined Your firm’s design validation failed to...Read More

Company: Able Laboratories Inc.Product: Lithium, methylphenidate, phentermine and other drugs Date: 4/19/04 The MedWatch forms which you submitted were on FDA form 3500, which is for the voluntary reporting of ADEs by healthcare workers and consumers. As a drug manufacturer, you must be reporting all domestic ADEs on FDA MedWatch form 3500A. Reports of foreign...Read More

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Company: Cordis Corp.Product: “Cypher Sirolimus-Eluting Coronary Stent” Date: 4/1/04 Failure to adequately validate for its intended purpose and according to an established protocol computer software used as part of the production or quality system, and failure to document validation activities and results, as required by 21 CFR 820.70(i). The automated _____ data acquisition system, used...Read More

Recipient:Cordis Corporation Product: Sirolimus-Eluting Coronary Stent Date: 4/1/2004 Failure to validate with a high degree of assurance, processes, including changed processes, that cannot be fully verified by subsequent investigation and test, as required by 21 CFR 820.75(a) & (c). For example: The automated [redacted] data acquisition system, used to ensure the integrity of the analytical...Read More

Company: General Electric Medical Systems Information TechnologyDate of Enforcement Report: 3/31/04 Class: II PRODUCT PatientNet Monitoring System – PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx. Recall # Z-0727-04. REASON Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly. CODE All PatientNet Central Stations. RECALLING FIRM/MANUFACTURER General...Read More

Company: Instrumentation Laboratory CoDate of Enforcement Report: 3/31/04 Class: II PRODUCT a) ACL Futura Instrument Analyzer. Recall # Z-0736-04; b) ACL Advance Instrument Analyzer. Recall # Z-0737-04. REASON Software may cause instrument to omit step causing reagent carryover which may effect patient test result. CODE a) Software prior to Version V3-5; b) Software version prior...Read More

Company: Siemans Medial Solutions USA, Inc CoDate of Enforcement Report: 3/31/04 Class: III PRODUCT Acuson Cypress Echocardiography System. Catalog number 8264604; Recall # Z-0744-04. REASON Software problem – mode does not appear on screen. CODE Serial numbers 73480 through 73535, 71165, 71561, 72532, 73125, and 73292. RECALLING FIRM/MANUFACTURER Siemans Medial Solutions USA, Inc, Plymouth Meeting,...Read More

Company: Coherent Inc Laser GroupsDate of Enforcement Report: 3/24/04 Class: I PRODUCT Coherent brand Quattro Diode Laser Systems; A Quattro FAP System. Recall # Z-0357-04. REASON Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated. CODE Serial Numbers/Model Numbers: TFAP0004P-TFAP00048. RECALLING FIRM/MANUFACTURER Coherent Inc...Read More

Company: Beckman Coulter IncDate of Enforcement Report: 3/24/04 Class: II PRODUCT a) CXP software, Part No. 623560. Recall # Z-0635-04; b) Cytomics MXP Software, Part No. 623688. Recall # Z-036-04; c) Cytomics RXP Software, Part Numbers: 175488, 6418489, 175260, 175261, 175262, 175263, 175264, 175265. Recall # Z-0637-04. REASON Software anomaly. Sample ID and the Run...Read More

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The AAMI Software Risk Management Technical Information Report draft comment period ended March 1, 2004. Comments were generally positive.The next step is a working group meeting May 11-12, 2004 to resolve comments and do a final edit to prepare the document for formal ballot. Contact one of the co-chairs if you are not a member...Read More

Company: Michigan Instruments Inc.Product: Thumper Model 1007 Mechanical CPR System Date: 3/23/04 You failed to perform or document the verification or validation of production process changes, such as the Inspiratory Time Test Specification, _____ on 12/17/2002 and the _____ software changes on 11/7/2000 (FDA-483 #11, c. and # 11, i) as required by 21 CFR...Read More

http://www.pti-international.com/computervalidation/Read More

FDA has been investigating putting together information on hazards of various types of devices as an aide to both FDA and industry. Sandy Weininger at CDRH has established a forum for dissemination of information on this project. If you are interested in participating or receiving updates on this effort send email to office@softwarecpr.com or directly...Read More

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Company: American Red Cross Transplantation ServicesProduct: Cryopreserved heart valves Date: 3/11/04 The cryopreservation process dated 5/19/95, Computer Rate Controlled Freezer for Cryopreservation of Human Tissue, was not adequate. The validation included determining the maximum tolerance limits of the cryopreservation unit to freeze heart valves at a specified rate but only cryopreservation solution was used, not...Read More

Company:Toshiba American Med SysDate of Enforcement Report: 3/10/04 Class: III PRODUCT Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models. Recall # Z-0546-04. REASON Software anomally causes image slices to be in incorrect order. CODE Flexart systems with software V3.51*R534 to V4.10*R551. Visart systems with software V3.51*R234 to V4.10*R251. Excelart systems with software V4.04*R251 to...Read More

Company: Varian Medical SystemsDate of Enforcement Report: 3/10/04 Class: II PRODUCT EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader. Recall # Z-0582-04. REASON Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy CODE Serial numbers (Domestic units): 724 215 765 210 212...Read More

Company: Health Directions Inc.Product: Health Pax Cranial Electrotherapy Stimulator Device Date: 3/4/04 -“Most recently, the dramatic evidence of the efficacy of CES entails use of computerized EEG’s or topographical brain mapping, validating that CES alters the abnormal electrophysiology associated with drug/alcohol abuse and other organic brain diseases as well as normalizing other dysfunctional brain wave...Read More

Company: Soft Computer Consultants, Inc.Date of Enforcement Report: 3/3/04 Class: II PRODUCT “Softbank II” Laboratory Information System. Recall # B-0841-4. REASON Defects in the design of blood bank software program could result in incorrect patient laboratory records. CODE V.19, V.21, and V.22; Release 3.1.3. RECALLING FIRM/MANUFACTURER Soft Computer Consultants, Inc., Palm Harbor, FL, by telephone...Read More

Company: Coherent, Inc.Date of Enforcement Report: 3/3/04 Class: II PRODUCT Quattro FAP System, Class IV multi-wavelength laser diode material processing machine. Recall # Z-0357-04. REASON Performance requirement-safety interlocks malfunction due to improper information included in the software operating the laser CODE None. RECALLING FIRM/MANUFACTURER Coherent, Inc, Santa Clara, CA, by technician visit to install software,...Read More

Company: Ocuserv Instruments Inc.Product: Ultrasonic Imaging Systems, Autoscan DB 3000, DB 3000C Biometric Rulers and Ophthalmic A-Scan Systems Date: 3/2/04 During an inspection of your firm located in Jamaica, New York, conducted during the dates of January 13, 14 & 23, 2004, our investigator determined that your firm manufactures medical devices under the brand names...Read More

Company: MedRx Inc.Product: “Otowizard” and “Vet Digitizer” Date: 3/1/04 Your firm failed to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality as required by 21 CFR 820.70(c). There was no electro-static discharge (ESD) procedures or other precautions in effect when electronic...Read More

Company: GVI Technology PartnerDate of Enforcement Report: 2/18/04 Class: III PRODUCT CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version BIA. Recall # Z-0527-04. REASON Due to limitations in the operating software, the acquired scan may not be processed properly. CODE S/Ns: 100 thru 105, and 107 thru 116. RECALLING FIRM/MANUFACTURER GVI...Read More

Company: Medtronic MiniMedDate of Enforcement Report: 2/18/04 Class: III PRODUCT Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software. Recall #Z-0531-04. REASON A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software. CODE All...Read More

Company: Cerner CorporationDate of Enforcement Report: 2/11/04 Class: II PRODUCT Cerner HNA Classic Patient Management (U60)/Patient Linking (PHC) software, HNA Classic 306. Recall # B-0440-4. REASON Blood bank software, which included a defect that could result in the failure to accurately display all alloantibodies when linking or combining medical records for the same patient, was...Read More

Company: Shanghai Medical Ltd.Product: Active pharmaceutical ingredients Date: 2/10/04 One of the discussion points with management concerned missing data for the analysis of [redacted] and [redacted] by [redacted] There were six entries in the [redacted] logbook that could not be found in the correlating computer files. The investigative team was together during the interaction with...Read More

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