Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Syngo Imaging XS is a Picture Archiving and Communication System (PACS) Recall Number Z-0550-2016 REASON For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction...Read More

Company: Shimadzu Medical Systems.Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Mobile X-ray system MobileDaRt Evolution/FDR Go Software Recall Number Z-0451-2016 REASON Shimadzu Corporation is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly… RECALLING FIRM/MANUFACTURER Shimadzu Medical Systems, Torrence, CA on 11/10/2015. Voluntary: Firm Initiated recall is...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Ingenuity CT Computed Tomography X-ray system Recall Number Z-0549-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Brilliance iCT SP Computed Tomography X-ray system Recall Number Z-0546-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Brilliance iCT Computed Tomography X-ray system Recall Number Z-0545-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Brilliance 64 Computed Tomography X-ray system Recall Number Z-0544-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Ingenuity Core Computed Tomography X-ray system Recall Number Z-0547-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Ingenuity Core 128 Computed Tomography X-ray system Recall Number Z-0548-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the...Read More

Company: Draeger Medical, Inc. Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients. Recall Number Z-0436-2016 REASON The firm became aware of cases in which the battery...Read More