Tag

recall

Software Recall

Company: Varian Medical Systems Inc, Date of Enforcement Report 2/20/2008 Class:ll PRODUCT Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models, Recall # Z-0720-2008 REASON Incorrect Software Validation. The ARC treatment plans containing a Dose Dynamic MLC for IMRT...
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Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 2/20/2008 Class:ll PRODUCT Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Recall # Z-0719-2008 REASON Software error: Error affects all Aspen customer systems using the PAL video standard configuration and has a Perspective PC installed. This can lead to a...
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Company: Sunquest Information Systems, Inc., Date of Enforcement Report 2/13/2008 Class:ll PRODUCT Sunquest Laboratory Blood Bank and Blood Donor, version 6.0.1 and 6.0.2, Recall # B-0663-08 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by e-mail on December 14. 2007. Firm initiated recall is ongoing. VOLUME...
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Company: General Electric Medical Systems Information Technology Date of Enforcement Report 2/13/2008 Class:ll PRODUCT GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (CIC Pro v4.1). (System hardware consists of a processing unit and a monitor), Recall # Z-0280-2008 REASON Two separate issues may occur with operating The CiC Pro v4.1 System...
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Company: Novartis Vaccines and Diagnostic Date of Enforcement Report 2/13/2008 Class:ll PRODUCT Procleix NAT Tracker Version 3.0 Software, Stand Alone Blood, Recall # B-0662-08 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER Novartis Vaccines and Diagnostic, Emeryville, CA, by letter on August 2, 2007 with a follow up letter on August 9,...
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Company: Varian Medical Systems, Inc., Date of Enforcement Report 2/6/2008 Class:ll PRODUCT Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models, Recall # Z-0554-2008 REASON Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets...
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Company: Vital Images, Inc., Date of Enforcement Report 2/6/2008 Class:ll PRODUCT Vital Images ViTALConnect, Version 4.0 and 4.1, PET/CT Visualization option. (A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze...
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Company: Baxter Healthcare Renal Division Date of Enforcement Report 2/6/2008 Class:ll PRODUCT Baxter RenalSoft v.2.0 Patient Management Software Suite – HD Module; clinical data management software, Recall # Z-0527-2008; b) Baxter Renal Software Suite v.3.0 and v.3.1 – Renal Link HD Module; clinical data management software; Recall # Z-0528-2008 REASON Pre-Treatment/Post-Treatment Report errors: 1) The...
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Company: Cyberonics, Inc., , Date of Enforcement Report 2/6/2008 Class:lll PRODUCT Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and preprogrammed with software v7.1 and higher, Recall # 0568-2008 REASON Screen Freezes– The Dell X5 Handheld PC screen will freeze caused due to incompatibility between the Microsoft 2002 OS and...
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Company: Visx, Inc Date of Enforcement Report 1/30/2008 Class:ll PRODUCT Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478, Recall # Z-0365-2008 REASON Erroneous Treatment Calculations – Two software caused errors; in combination, in the WaveScan System Software, will result in an erroneous treatment calculation (overcorrection) in patients. (1) Installation of software...
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Company: SCC Soft Computer Date of Enforcement Report 1/30/2008 Class:ll PRODUCT SoftBank II version 23.1, 23.1.1.x . , 23.1.2.x With Softscape 1.2.0.x, Recall # B-0505-08 REASON Software with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwater, FL, by Task Management Notification and telephone on September 19, 2007. Firm initiated recall is...
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Company: Datascope Date of Enforcement Report 1/23/2008 Class:lll PRODUCT Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608; Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Recall # Z-0150-2008 REASON Display problems: If an ECG cable, which has been damaged due to the ingress of liquid or by mechanical trauma, is utilized with...
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Company: SCC Soft Computer Date of Enforcement Report 1/16/2008 Class:ll PRODUCT Softbank II Software Version 23.1 with database Management System Interface. Report Unique Identifier: 1058332-04/07/2006-011-C, Recall # B-0504-08 REASON Software with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER SSCC Soft Computer, Clearwater, FL, by e-mail on May 9, 2005. Firm initiated recall is complete....
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Company: Toshiba American Med Sys Inc., Date of Enforcement Report 1/16/2008 Class:ll PRODUCT Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Recall # Z-0305-2008 REASON Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel...
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Company: Siemens Medical Solutions USA, Inc., Date of Enforcement Report 1/16/2008 Class:ll PRODUCT a) Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N: 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for premium edition, Recall # Z-0297-2008; b) Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version...
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Company: Ellex, Inc., Date of Enforcement Report 1/2/2008 Class:ll PRODUCT Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Recall # Z-0148-2008 REASON Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations....
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Company: Philips Medical Systems Date of Enforcement Report 1/2/2008 Class:ll PRODUCT a) Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. (The product is a software application that is installed in Philips Medical System CT scanners.), Recall # Z-0366-2008; b) Philips Medical Systems, Cardiac...
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Company:Beckman Coulter Inc Date of Enforcement Report 1/2/2008 Class:ll PRODUCT a) COULTER LH750 Analyzer, Part Number: 6605632, Hematology analyzer, Recall # Z-0312-2008; b) COULTER LH780 Analyzer, Part Number: 723585, Hematology analyzer, Recall # Z-0313-2008; c) COULTER LH 500 Series System, Part Number: 178833, Hematology analyzer, Recall # Z-0314-2008; d) COULTER GEN*S System, Part Number: 6605381,...
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Company: Medtronic Navigation, Inc Date of Enforcement Report:12/26/2007 Class:lll PRODUCT Ortho Assay Software (OAS) Version 2.0.1. There is no product code for the OAS. OAS software is pre-loaded on the OAS workstation. The workstation on which the software is loaded has two product codes: Product Code 936415 – April 4, 1999 to April 24, 2007...
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Company: Data Innovations, Inc., Date of Enforcement Report:12/26/2007 Class:ll PRODUCT Data Innovations Instrument Manager Software versions 7.04.0001 through 8.04.03.01, Recall # B-0195-08 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Data Innovations, Inc., South Burlington, VT, by e-mail on September 19, 2007 and by follow-up letter dated October 11, 2007. Firm initiated...
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Company:Abbott Laboratories, Inc Date of Enforcement Report:12/19/2007 Class:ll PRODUCT a) ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106- 01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10, Recall $ Z-0146-2008; b) ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20,...
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Company: Philips Medical Systems Date of Enforcement Report:12/195/2007 Class:ll PRODUCT Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Recall Z-0451-2008 REASON Alarm failure: If changes are made to the Care Group Editor configuration, Care Group alarm status,...
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Company: Accuray Inc, Date of Enforcement Report:12/19/2007 Class:ll PRODUCT Accuray, Multiplan Treatment Planning Software, Recall # Z-0364-2008 REASON Software problem – Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation. RECALLING FIRM/MANUFACTURER Accuray Inc, Sunnyvale, CA, by Urgent Advisory Notification on March...
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Company: GE Healthcare Advantage WorkstationsDate of Enforcement Report:12/19/2007 Class:ll PRODUCT GE Healthcare Advantage Workstations, Advantage Workstation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel...
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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...
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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...
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Company: Medtronic Navigation, Inc Date of Enforcement Report:12/5/2007 Class:ll PRODUCT Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, (software version 3.0), Recall # Z-0294-2008 REASON Reversed Instrument Position: a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180′ on the StealthStation image. (If...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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,...
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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...
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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...
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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...
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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...
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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...
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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...
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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,...
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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...
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