The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, whole body (WB) and SPECT applications. The Symbia Intevo Excel integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia Intevo 2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia Intevo 6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia Intevo 16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. Indications for use: SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
- Recall Initiated
- July 28, 2014
- Posted
- September 29, 2014
- Terminated
- December 23, 2016
- Recall Number
- Z-2713-2014
- Quantity
- 48 systems
- Firm Location
- Hoffman Estates, IL
Reason for Recall
Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in t
Distribution
Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WAM WI, WY, District of Columbia, Puerto Rico and Internationally to Algeria, Argentina , Australia , Austria , Bangladesh , Belgium , Brazil , Bulgaria , Canada , Chile , China, Colombia , Croatia , Czech Republic , Denmark , Ecuador , Egypt , Finland , France , Germany , Hong Kong , Hungary , India , Indonesia , Iran , Ireland , Israel , Italy , Japan , Kazakhstan , Korea, Kuwait , Latvia , Libya , Lithuania , Malaysia , Mexico , Morocco , Myanmar , Netherlands , New Zealand , Norway , Oman , Pakistan , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia, Saudi Arabia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Thailand , Tunisia , Turkey , United Arab Emirates , Ukraine , United Kingdom , Vietnam
Lot / Code Info
1) Symbia Intevo Excel; Product Code: 10764801; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008, 1009 , 1010 , 1011 , 1012 , 1013 , 1014 ; 2) Symbia Intevo 2; Product Code: 10764802; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 2001; 3) Symbia Intevo 6; Product Code: 10764803; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012, 2001; 4) Symbia Intevo 16; Product Code: 10764804; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015
Root Cause
Component design/selection
Action Taken
Siemens sent an Undated Customer Safety Advisory Notice letter to all direct accounts (customers). The letters included instructions for customers to: 1) continue to use the system(s) while waiting for the field correction to be scheduled and performed unless the system exhibits abnormal noise or vibration in which case the system(s) should not be used and the local Siemens Medical Solutions USA service engineer should be contacted; 2) ensure that the letter is placed in the Systems Owner's Manual and share it with support staff; and, 3) if the product was sold to another party, forward the letter to that party. A local service engineer will contact the customer to schedule the servicing of the affected systems by December 2014 which will consist of replacing the mounting plate. If customers have any questions about this issue, customer can contact their local service representative by calling 800-888-7436.