Company:Sendx Medical IncDate of Enforcement Report:9.5/2007 Class:ll PRODUCT ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863, Recall # Z-1201-2007 REASON The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the...Read More

The pdf at the link provided is a reprint of an article entitled “Risk-Based Validation of Multilingual Medical Devices” co-authored by Alan Kusinitz, Managing Partner of SoftwareCPR, and Kai Simonsen of the Crimson Life Sciences division Transperfect Translations for the AAMI Biomedical Instrumentation and Technology journal and published in the Summer of 2007. Reprinted with...Read More

Company:Dade Behring, IncDate of Enforcement Report:8/29/2007 Class:ll PRODUCT EasyLink Informatics System, software version 3.0, Part Number 1000034941, Recall # Z-1174-2007 REASON Sample ID and Patient results could be associated with the wrong patient. RECALLING FIRM/MANUFACTURER Dade Behring, Inc., Newark, DE, by letter dated July 3, 2007. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company:GE Healthcare Date of Enforcement Report:8/21/2007 Class:ll PRODUCT a) GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE, Recall # Z-1132-2007; b) GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE, Recall # Z-1133-2007; c) GE Healthcare Systems ComboLab System. Made up...Read More

Company: Abbott LaboratoriesDate of Enforcement Report:8/22/2007 Class:ll PRODUCT a) CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled medical device for diagnostic use., and CELL DYN Control Assay Disk, List Numbers 01H91-01 and 01H92-01 when used with above CELL DYN 1700, Recall # Z-1170-2007 b) Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers...Read More

Company:Northwest Medical Physics Equipment, IncDate of Enforcement Report:8/15/2007 Class:ll PRODUCT ISOLOC 4.2 Software Part Number NT-NW-425-520. Radiation treatment software, Recall # Z-1147-2007p> REASON When the ISOLOC (Version 4.2) profile distance unit is set to “centimeter” and the user clicked the “back” button in the digitizer window, the marker and target coordinates in the localization window...Read More

Company:Northwest Medical Physics Equipment, IncDate of Enforcement Report:8/15/2007 Class:ll PRODUCT Isoloc software Version 6.5, Part Number NT-NW-425-520. Software for image guided radiation therapy, Recall # Z-1145-2007p> REASON Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to “Anatomic Landmark” setting. RECALLING FIRM/MANUFACTURER Northwest Medical Physics Equipment, Inc., Everett,...Read More

Company:Northwest Medical Physics Equipment, IncDate of Enforcement Report:8/15/2007 Class:ll PRODUCT ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment, Recall # Z-1146-2007p> REASON This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update...Read More

Company:Medtronic Emergency Response Systems, IncDate of Enforcement Report:8/8/2007 Class:ll PRODUCT Biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers), Recall # Z-1148-2007 REASON Reduced Shock. The device may deliver 100 Joule (J) to a patient, which is less than...Read More

Company:Roche Molecular Systems, IncDate of Enforcement Report:8/8/2007 Class:ll PRODUCT a) Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests, Recall # Z-1106-2007; b) Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0, Catalog number 03576710190, Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122,...Read More

Company:Radiometer America IncDate of Enforcement Report:8/1/2007 Class:ll PRODUCT a) ABL 700 Series blood gas analyzers equipped with Software Version 3.833, Recall # Z-1094-2007; b) ABL 800 FLEX series blood gas analyzers containing software version 5.24, Recall # Z-1095-2007; REASON Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of...Read More

Company:Baxter Healthcare CorpDate of Enforcement Report:7/25/2007 Class:l PRODUCT Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore, product codes 2M8153, 2M8163, 2M9163, Recall # Z-1091-2007 REASON A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming...Read More

/Docs/PulseOximeterDraftGuidance071907.pdfRead More

Company:Brainlab AGDate of Enforcement Report:7/11/2007 Class:ll PRODUCT BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; catalog/version number 40700-3A, Recall # Z-1010-2007 REASON Target Alignment Error. A mechanical component/software incompatibility caused by a specific combination of the BrainLAB...Read More

Company:bioMerieux, Inc Date of Enforcement Report:7/11/2007 Class:ll PRODUCT a) Vitatron C-Series dual chamber Rate Responsive Pacemakers (C60DR) includes the following models: C60A1 and C60A3 for US distribution and C50A1, ..A2, A3, C60A2 for international distribution (the single chamber is not involved). C-series software is VSF11/VSF12 Version 1.0. Recall # Z-0999-2007; b) Vitatron T-Series Dual Chamber...Read More

Company:Varian Medical Systems Inc. Date of Enforcement Report:7/4/2007 Class:ll PRODUCT LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1., Recall # Z-0978-2007 REASON A software anomaly in a medical device used for patient treatment could result in accidental or unintended radiation exposure. The tilt rotation compensation algorithm does not adequately...Read More

Company:Toshiba American Med Sys Inc Date of Enforcement Report:7/4/2007 Class:ll PRODUCT a) Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software, Recall # Z-0985-2007; b) Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software, Recall # Z-0986-2007 REASON When using the LV measurement function and making numerous measurements the value displayed...Read More

/docs/SCPRed/SoftwareCPR-Newsletter0607.pdfRead More

Company:Abbott Laboratories, Inc., Date of Enforcement Report:6/27/2007 Class:ll PRODUCT ) ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; Recall # Z-0950-2007; b) ARCHITECT i2000sr Processing Module, for in vitro diagnostics; List Number: 3M74-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; Recall...Read More

Company:General Electric Medical Systems Information Technology Date of Enforcement Report:6/20/2007 Class:ll PRODUCT GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (System hardware consists of a processing unit and a monitor), Patient Monitor, Recall # Z-0891-2007 REASON Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when...Read More

Company:Medtronic Emergency Response Systems, Date of Enforcement Report:6/13/2007 Class:ll PRODUCT LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics. Affected part numbers: 3202487-073 through -083; 3202487-087 through -090; 3202487-092; 3202487-093; 3202487-098; 3202488-036; 3202488-038...Read More

Company:General Electric Med Systems LLC, Date of Enforcement Report:6/6/2007 Class:ll PRODUCT a) GE Healthcare Innnova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System), Recall # Z-0869-2007; b) GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System), Recall # Z-0870-2007; c) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile...Read More

Company: Abbott Diabetes Care, Inc Date of Enforcement Report:5/30/2007 Class:ll PRODUCT Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); Part Numbers: 99040-01, 99063-02.99514-01,97444-04, 97444-05,97445-05,97570-04, 98891-04,98929-05,98931-04, 98889-06, 98890-05, 98891-05, 98929-06,98931-05,99063-04, 99516-03, 80378-01,80379-01,80380-01, 80381-01, 80382-01,80383-01, 80392-01, 70519-01, 80392-02, Recall # Z-0709-2007 REASON If the time and date are...Read More

Company:GE Healthcare-Americas Signa 3.0T EXCITE Date of Enforcement Report:5/23/2007 Class:ll PRODUCT GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance system, Recall # Z-0815-2007 REASON To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included...Read More

Recipient: Medico Labs, Inc. Product:drug products Date:4/16/2007 An inspection of your manufacturing facility was conducted from November 2 through November 16, 2006. During the inspection, our investigator documented deviations from the Current Good Manufacturing Practice (CGMP) Regulations, Title 21 Code of Federal Regulations, Parts 210 and 211 (21 CFR 210 and 211) for drug products...Read More

Company:Misys Healthcare Systems Date of Enforcement Report:5/16/2007 Class:lll PRODUCT Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0114-07 REASON Blood Bank software, containing a glitch or defect, was distributed. CODE Version 6.1 and 6.2 RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by e-mail dated July 27, 2006. Firm initiated recall is ongoing. VOLUME...Read More

Company:Misys Healthcare Systems Date of Enforcement Report:5/16/2007 Class:lll PRODUCT Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0115-07 REASON Blood Bank software, containing a glitch or defect, was distributed. CODE Version 6.1 and 6.2 RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by e-mail dated August 16, 2006. Firm initiated recall is ongoing. VOLUME...Read More

Company:Misys Healthcare Systems Date of Enforcement Report:5/16/2007 Class:lll PRODUCT Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0561-07 REASON Blood Bank software, containing a glitch or defect, was distributed. CODE Version 6.1 and 6.2 RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by e-mail dated November 10, 2006. Firm initiated recall is ongoing. VOLUME...Read More

Company:Misys Healthcare Systems Date of Enforcement Report:5/16/2007 Class:lll PRODUCT Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0549-07 REASON Blood Bank software, containing a glitch or defect, was distributed. CODE Version 6.1 and 6.2 RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by e-mail dated November 8, 2006. Firm initiated recall is ongoing VOLUME...Read More

Company:bioMerieux, Inc., Date of Enforcement Report:5/9/2007 Class:ll PRODUCT a) BacT/ALERT Classic System Software, Blood Culturing System, Recall # Z-0773-2007; b) BacT/ALERT 3D System Software, Blood Culturing System, Recall # Z-0774-2007; c) BacT/ALERT 3D Combo Systems Software, Blood Culturing System, Recall # Z-0775-2007; d) BacT/ALERT 3D 60 Systems Software, Blood Culturing System, Recall # Z-0776-2007 REASON...Read More

Company:Toshiba American Med Sys Inc., Date of Enforcement Report:5/9/2007 Class:ll PRODUCT Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Recall # Z-0771-2007 REASON Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature...Read More

Company:Instrumentation Laboratory Co., Lexington, MA, Date of Enforcement Report:5/9/2007 Class:ll PRODUCT GEM Premier 4000 Laboratory Analyzer, Recall # Z-0778-2007 REASON Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result. CODE Serial numbers prior to 07020343 with Software versions prior to V1.1.3 RECALLING FIRM/MANUFACTURER...Read More

/Docs/FDAClinicalTrialsComputerSystemGuidance-051007-04d-0440-gdl0002.pdfRead More

Company:Smiths Medical MD, Inc., . Date of Enforcement Report:5/2/2007 Class:ll PRODUCT Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4, Recall # Z-0768-2007 REASON Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump’s startup sequence when the pump’s Preventative Maintenance...Read More

/Docs/ComputerizedLaborMonitoringSystemGuidance042407.pdfRead More

/Docs/ComputerizedLaborMonitoringSystemClassificationRule042407.pdfRead More

RecipientG&B Electronic Designs Limited Product: Tracklt and NicoletOne Ambulatory Electroencephalograph Recorder devices Date:4/24/2007 Failure to assure that when computers or automated data processing systems are used as part of the production or quality system the manufacturer shall validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i)....Read More

Company:Radiometer America Inc. Date of Enforcement Report:4/11/2007 Class:ll PRODUCT ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27, Recall # Z-0705-2007 REASON In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific...Read More

Company:Smiths Medical MD, Inc., . Date of Enforcement Report:4/11/2007 Class:ll PRODUCT Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP); RX ONLY, Recall # Z-0718-2007 REASON The year of manufacture had been incorrectly entered as 1980 into the...Read More

Company:Pulse Biomedical, IncDate of Enforcement Report:4/11/2007 Class:ll PRODUCT QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine, Recall # Z-0716-2007 REASON No 510 (k) marketing clearance for the product. CODE Serial numbers: 4605AU0251E, 2306AU0600E-BT, 2306AU0601E-BT, 2406AU0610E-BT, and 2706AU0641E-BT. RECALLING FIRM/MANUFACTURER...Read More

The EU parliament reviewed the suggested changes to the Medical Device Directives including software related changes. The full Oct 2006 report is at the link provided. MDDRead 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

Recipient: MRL, Inc.. Product: automatic external defibrillators Date:12/8/06 We have reviewed your response to FDA-483 Observation # 12 and conclude that the plan was adequate; but without completion of the databases we have no assurance that its implementation will be adequate. 10. Failure to have production and process controls for automated processes, as required by...Read More

Recipient:Edwards Life Sciences, LLC Product: Swan-Ganz Continuous Cardiac Output (CCO) Catheter, Vigilance Monitors, and stents Date:2/5/2007 Failure to submit a supplemental report to FDA within 1 month of receipt of information that was known to you regarding a serious injury reportable under 21 CFR 803.50, as required by 21 CFR 803.56. For example, b) A...Read More

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

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: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: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: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