Z-2713-2014 Class II Terminated
Recalled by Siemens Medical Solutions USA, Inc.
— Hoffman Estates, IL
FDA device recall Z-2713-2014 was initiated by Siemens Medical Solutions USA, Inc. on Jul 28, 2014 and is designated Class II. 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… The recall status is terminated (terminated Dec 23, 2016). Affected quantity: 48 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 8, 2014
- Initiation Date
- Jul 28, 2014
- Termination Date
- Dec 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 systems
Product Description
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.
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 Pattern
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
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2713-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.