Day

November 23, 2016
Company: Sorin Group USA, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients. Recall Number Z-0413-2017...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/23/2016 Class lI: PRODUCT SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/23/2016 Class lI: PRODUCT SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 11/23/2016 Class lI: PRODUCT SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different...
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Company: Mevion Medical Systems, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT MEVION S250 Product Usage: Proton Radiation Therapy System Recall Number Z-0411-2017 REASON Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography. Recall Number Z-0599-2017 REASON The software did not show unviewed images when...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT MergeMerge LIS software Recall Number Z-0399-2017 REASON There is a potential for duplicate container numbers to be created for patients.. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on 11/11/2016. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 413 sites potentially...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT MergeMerge LIS software Recall Number Z-0611-2017 REASON Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on 11/17/2016. Voluntary: Firm Initiated recall is ongoing....
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Company: Roche Diabetes Care Date of Enforcement Report 11/23/2016 Class lI: PRODUCT Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016 Recall Number Z-0586-2017 REASON Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due...
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