Company:Misys Healthcare Systems Date of Enforcement Report:12.5/2007 Class:ll PRODUCT Misys Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2, Recall # B-0317-08 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems dba Misys Hospital Systems, Tucson, AZ, by e-mail on August 24, 2007. Firm initiated recall is ongoing. VOLUME...Read More

Company:Toshiba America Medical Systems, Inc., Date of Enforcement Report:12/5/2007 Class:ll PRODUCT Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equipped with Digital Radiography System with Software version 3.4er000, Recall # Z-0293-2008 REASON System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.. RECALLING FIRM/MANUFACTURER Recalling Firm: Toshiba America Medical...Read More

Company:Siemens Medical Solutions USA, Inc., Date of Enforcement Report:12/5/2007 Class:ll PRODUCT a) Siemens ECAT ACCEL, Catalog No. 3545584, PET/CT Scanner, Recall # Z-0269-2008; b) Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Recall # Z-0270-2008; c) Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner, Recall # Z-0271-2008; d) Siemens ECAT EXACT HR 47, Catalog...Read More

Company: Philips Medical Systems t Date of Enforcement Report:11/28/2007 Class:ll PRODUCT Philips, Voxel Q workstations, utilizing AcQSim or AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 and any Mx8000, Mx8001DT, or Brilliance 6, 10, 16, 16P, and Big Bore CT systems connected to the VoxelQ, Recall # Z-0180-2008 REASON...Read More

Company: Toshiba American Med Sys IncDate of Enforcement Report:11/21/2007 Class:ll PRODUCT a) NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Recall $ Z-0253-2008; b) NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5.000B, V2.0.0, Recall...Read More

Company:GE Healthcare Date of Enforcement Report:11/14/2007 Class:ll PRODUCT GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; Recall # Z-0113-2008 REASON When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is...Read More

Company: Medtronic Inc. Cardiac Rhythm Management Date of Enforcement Report:11/14/2007 Class:lll PRODUCT Medtronic Paceart System, 2006 Edition, The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices; Recall # Recall...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report:11/14/2007 Class:ll PRODUCT The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application. All Brilliance CT Big Bore Scanners with Tumor Localization software versions v2.2.1, v2.2.2, & v2.2.5. This software version is...Read More

Company: Medtronic Neurological, Date of Enforcement Report:10/17/2007 Class:ll PRODUCT Medtronic InterStim II INS Model 3058 with N’Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N’Vision with a Clinican Programmer Model 8840. Implantable Neurostimulator for Urinary Control. Catalog # 8870MM01 & 8870NNB01, Recall # Z-0037-2008 REASON A software issue may cause a lower than...Read More

Company: Naviscan PET Systems Date of Enforcement Report:10/17/2007 Class:lll PRODUCT PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging, Recall # Z-0041-2008 REASON Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired...Read More

Company: Beckman Coulter Incl, Date of Enforcement Report:10/24/2007 Class:ll PRODUCT FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use. Recall # Z-0002-2008 REASON Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter...Read More

Company:Baxa Corporation, IncDate of Enforcement Report:10/3/2007 Class:l PRODUCT Exacta-Mix 2400 OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Recall # Z-1238-2007 REASON A software defect could allow up to 50mL of extra volume being added to a TPN (Total Parenteral Nutrition) solution. RECALLING FIRM/MANUFACTURER Baxa Corporation, Englewood, CO, by telephone and letter on June 27,...Read More

Company:Intuitive Surgical, Inc., Date of Enforcement Report:10/3/2007 Class:ll PRODUCT Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Recall # Z-1244-2007 REASON Under certain circumstances, the product’s software may crash and require a manual override or restart before functioning again. In addition, there is an unrelated addendum to the User Manual...Read More

Company:Cerner Corp.Date of Enforcement Report:10/3/2007 Class:ll PRODUCT Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities Recall # Z-1243-2007 REASON Defects in the Auto Launch functionality make it possible for a mismatch of patient data. RECALLING FIRM/MANUFACTURER Cerner Corp., Kansas City, MO, by telephone on August 23, 2007 and by letters dated...Read More

Company:Misys Encompass Versions 2.2.1, 2.3 and 2.4sDate of Enforcement Report:10/3/2007 Class:ll PRODUCT Misys Encompass Versions 2.2.1, 2.3 and 2.4, Recall # B-1557-07 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems dba Misys Hospital Systems, Tucson, AZ, by e-mail on April 16, 2007. Firm initiated recall is ongoing.. VOLUME OF...Read More

Company:Philips Nuclear Medicine, Inc., Date of Enforcement Report:10/3/2007 Class:ll PRODUCT The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including the core Pinnacle3 functionality, Syntegra (TM), P3IMRT, P3MD and AcQSim3 (TM). The Pinnacle3 RTP system is composed of a Sun UNIX workstation (or UNIX-complaint computer) running the Solaris operating...Read More

Company:Roche Molecular Systems, IncDate of Enforcement Report:10/3/2007 Class:ll PRODUCT Ampilink Software versions 1.1, 1.3, 1.4, 2.41 and 2.42 [COBAS AmpliPrep/COBAS Amplicor HIV-1 Monitor v1.5 test; COBAS Amplicor HIV-1 Monitor test v1.5; COBAS AmpliScreen HBV Test; COBAS AmpliScreen HCV Test, version 2; COBAS AmpliScreen HIV-1 Test, version 1.5], Recall # B-1554-07 REASON For select COBAS AMPLICOR...Read More

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

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

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: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: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

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: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

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: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-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: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

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: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

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: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: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

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