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Terminated

The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T 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, WB and SPECT applications. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia T2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia T6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia T16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. For the Symbia T16/T6/T2, the ultra fast multi-slice spiral CT maximizes confidence in diagnostic stand-alone CT, as well as precise attenuation correction and anatomical mapping. Acquisitions can be performed with either the CT preceding the nuclear acquisition or vice versa. 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.

FDA Recall Z-2712-2014 · Posted 2014-09-29

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2014-07-28
Date Terminated2016-12-23
Product Quantity1039 systems

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

Firm Action

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.

Root Cause

Component design/selection

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131634SYMBIASiemens Medical Solutions USA, Inc. · 2013-08-16K082506SYMBIA, VERSION 4.0Siemens Medical Solutions USA, Inc. · 2008-11-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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