Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT PRIMUS HI, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1402-2018 REASON Control Console software has been updated to reduce the risk for collision...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Impression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1400-2018 REASON Control Console software has been updated to reduce the risk for collision...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Impression plus, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1401-2018 REASON Control Console software has been updated to reduce the risk for...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1399-2018 REASON Control Console software has been updated to reduce the risk for collision...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. Recall Number: Z-1398-2018 REASON Control Console software has been updated to reduce the risk for collision...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. Recall Number: Z-1397-2018 REASON Control Console software has been updated to reduce the...Read More

Company:Philips Medical Systems (Cleveland) IncDate of Enforcement Report 4/25/2018 Class lI: PRODUCT ngenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of...Read More

Company:GE Medical Systems Ultrasound & Primary Care Diagnostics, Date of Enforcement Report 4/25/2018 Class lI: PRODUCT GE Healthcare:a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal...Read More

Company:GE Medical Systems Ultrasound & Primary Care Diagnostics, Date of Enforcement Report 4/25/2018 Class lI: PRODUCT 1. GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared...Read More