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...Read More

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:...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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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...Read More

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...Read More

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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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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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...Read More

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...Read More

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...Read More

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...Read More

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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...Read More

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...Read More

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...Read More