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Company: Draeger Medical, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT Perseus A500 Anesthesia Machine; Cat. no. MK06000Product VProduct Usage:Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring,...
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Company: Draeger Medical, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders....
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CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Apollo Anesthesia Machine; Cat. no. 8605310Product Usage:Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration...
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Company:Datex-Ohmeda, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that...
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Company:C.R. Bard, Inc. Date of Enforcement Report 6/27/2018 Class lI: PRODUCT CritiCore Automated Urine Output and Temperature Monitor Recall Number: Z-2243-2018 REASON Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.. RECALLING FIRM/MANUFACTURER C.R. Bard, Inc. Covington, GA on 11/10/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF...
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Company:Cyberonics, Inc. Date of Enforcement Report 6/27/2018 Class lI: PRODUCT VNS Therapy Programmer, Model 3000, v1.0 System Recall Number: Z-2255-2018 REASON Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: ” Delivery of more...
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CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series...
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CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series...
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CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series...
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CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Perseus A500 Anesthesia Machine; Cat. no. MK06000Product VProduct Usage:Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring, Recall Number:...
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Company:CellaVision AB. Date of Enforcement Report 6/20/2018 Class lI: PRODUCT CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies...
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Company:Shimadzu Medical Systems. Date of Enforcement Report 6/20/2018 Class lI: PRODUCT Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is...
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Company:Ion Beam Applications S.A.. Date of Enforcement Report 6/13/2018 Class lI: PRODUCT 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system. Recall...
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Company:Draeger Medical Systems, Inc. Date of Enforcement Report 6/13/2018 Class l: PRODUCT Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of...
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Company:Draeger Medical Systems, Inc. Date of Enforcement Report 6/13/2018 Class l: PRODUCT Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of...
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Company:GE Healthcare Date of Enforcement Report 6/13/2018 Class lI: PRODUCT Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks...
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Company:NordicNeuroLab AS Date of Enforcement Report 6/13/2018 Class lI: PRODUCT nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.. Recall Number: Z-2050-2018 REASON An error was discovered in the interpretation of certain DICOM header tags that may lead to...
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Company:NordicNeuroLab AS Date of Enforcement Report 6/13/2018 Class lI: PRODUCT nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis...
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Company:Invivo Corporation. Date of Enforcement Report 6/13/2018 Class lI: PRODUCT Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Recall Number: Z-2115-2018 REASON While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control...
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FDA issued the draft guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” June 7, 2018. Note that there are a variety of types of Q-submissions and they do not need to be tied to a specific planned 510(k) or other premarket submission. Also note that they are not meant to...
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Company:NordicNeuroLab AS Date of Enforcement Report 6/6/2018 Class lI: PRODUCT nordicBrainEXProduct Usage:nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical...
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Company:NordicNeuroLab AS Date of Enforcement Report 6/6/2018 Class lI: PRODUCT nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians. Recall Number: Z-2044-2018 REASON An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or...
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Company:NordicNeuroLab AS Date of Enforcement Report 6/6/2018 Class lI: PRODUCT nordicTumorEx 1.0nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 6/62018 Class lI: PRODUCT SOMATOM Go.Now, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans. Recall Number: Z-1939-2018 REASON There is a potential for a software issue that may cause the need for necessary patient...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 6/62018 Class lI: PRODUCT SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans. Recall Number: Z-1940-2018 REASON There is a potential for a software issue that may cause the need for necessary patient...
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FDA Issued a Proposed Order to Down-Classify Certain Radiological Medical Image Analyzers, which include computer-assisted detection devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices, from class III to class II devices.  If finalized, this proposed order will reclassify computer-assisted detection devices for certain radiological applications from...
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Company:Baxter Healthcare CorporationDate of Enforcement Report 5/30/2018 Class lI: PRODUCT Prismaflex 7.XX ROW, Product Code 114870: The Prismaflex Control Unit is intended for: ” Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. ” Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or...
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Company:Baxter Healthcare CorporationDate of Enforcement Report 5/30/2018 Class lI: PRODUCT Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: ” Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. ” Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/30/2018 Class lI: PRODUCT Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system Recall Number: Z-1930-2018 REASON Possibility that the Biograph Horizon systems performing CT retrospective...
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Company:Baxter Healthcare CorporationDate of Enforcement Report 5/30/2018 Class lI: PRODUCT Prismaflex 7.20 US: The Prismaflex Control Unit is intended for: ” Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. ” Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases...
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Company:Draegar Medical Systems, Inc. Date of Enforcement Report 5/23/2018 Class lI: PRODUCT Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained...
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Company:Invivo Corporation Date of Enforcement Report 5/23/2018 Class lI: PRODUCT PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only)The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Recall Number: Z-1867-2018 REASON The real-time numeric value for...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/23/2018 Class lI: PRODUCT SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system Recall Number: Z-1745-2018 REASON There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/23/2018 Class lI: PRODUCT SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system Recall Number: Z-1748-2018 REASON There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/16/2018 Class lI: PRODUCT Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/16/2018 Class lI: PRODUCT Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also...
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Company:Inpeco S.A. Date of Enforcement Report 5/16/2018 Class lI: PRODUCT FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System Recall Number: Z-1798-2018 REASON Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients RECALLING FIRM/MANUFACTURER Inpeco S.A....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/16/2018 Class lI: PRODUCT ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.. Recall Number: Z-1200-2018 REASON The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment. RECALLING FIRM/MANUFACTURER Siemens Medical...
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Company:Hitachi Ltd., Medical System Operations Group Date of Enforcement Report 5/9/2018 Class lI: PRODUCT MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall Number: Z-1585-2018 REASON Due to a system controller software anomaly, the...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1459-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based...
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Company:PerkinElmer Life and Analytical Sciences, Wallac, OYDate of Enforcement Report 5/9/2018 Class lI: PRODUCT Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1457-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Philips Electronics North America Corporation Date of Enforcement Report 5/9/2018 Class lI: PRODUCT Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1451-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior)...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1448-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1453-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT Biograph Horizon – PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner. Recall Number: Z-15972018 REASON Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1447-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior)...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1452-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1446-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1445-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1448-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1449-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior)...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1450-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Radiometer Medical ApSDate of Enforcement Report 5/9/2018 Class lI: PRODUCT AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1454-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Roche Diagnostics CorporationDate of Enforcement Report 5/9/2018 Class lI: PRODUCT cobas b 221Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1458-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Roche Diagnostics CorporationDate of Enforcement Report 5/9/2018 Class lI: PRODUCT cobas b 221Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1456-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Roche Diagnostics CorporationDate of Enforcement Report 5/9/2018 Class lI: PRODUCT cobas b 221Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1455-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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