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

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

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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...Read More

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 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...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

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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...Read More

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....Read More

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...Read More

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...Read More

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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....Read More

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....Read More

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)...Read More

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....Read More

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)...Read More

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....Read More

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...Read More

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....Read More

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...Read More

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....Read More

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...Read More

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....Read More

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....Read More

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....Read More

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....Read More

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...Read More

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...Read More

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...Read More

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....Read More