Day

June 15, 2016
Company: Sedecal USA, Inc.Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Sedecal SA Mobile Diagnost w DR x-ray system. Recall Number Z-1691-2016 REASON Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type ” Newborn”...
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Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System Recall Number Z-1719-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...
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Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Ingenuity CT Computed Tomography X-Ray System Recall Number Z-1717-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...
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Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System Recall Number Z-1718-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...
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Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Ingenuity Core Computed Tomography X-Ray System Recall Number Z-1716-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...
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Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare DuraDiagnost stationary X-ray system. Recall Number Z-1696-2016 REASON The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image. RECALLING FIRM/MANUFACTURER Philips Healthcare, Andover, MA on 11/10/2015. Voluntary: Firm...
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Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare DigitalDiagnost stationary X-ray system. Recall Number Z-1695-2016 REASON The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image. RECALLING FIRM/MANUFACTURER Philips Healthcare, Andover, MA on 11/10/2015. Voluntary: Firm...
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Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Brilliance iCT Computed Tomography X-Ray System Recall Number Z-1714-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...
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Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Brilliance 64 Computed Tomography X-Ray System Recall Number Z-1713-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...
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Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System Recall Number Z-171Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3)...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report 6/15/2016 Class lI: PRODUCT VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. Recall Number Z-1913-2016 REASON Ortho Clinical Diagnostics confirmed a software timing anomaly in which...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report 6/15/2016 Class lI: PRODUCT VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.. Recall Number Z-1914-2016 REASON Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600...
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Company: Brainlab AG Date of Enforcement Report 6/15/2016 Class lI: PRODUCT ExacTrac Vero is a Patient Positioning System for Radiation therapy. Recall Number Z-1729-2016 REASON Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5 RECALLING FIRM/MANUFACTURER Brainlab AG, Feldkirchen, Germany on 5/4/2016. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

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This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

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Instructor: Dr Peter Rech, 2nd instructor (optional)

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