Reported Oct 8, 2014 · 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…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 2501 Barrington Rd · Hoffman Estates, IL · 60195-2061
Is this the product you have?
- 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 useSPECT: To detect or image the distribution of radionuclides in the body or organ
- using the following techniquesplanar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV
- CTThe 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
- Lot codes and dates
- 1) Symbia T
- Product Code10275007
- Serial Numbers
359 of 359 codes
105510561057105810601061106210631064106510661067106810691070107110721073107410751076107710781079108010811082108310841085108610871088108910901091109210941095109610971098109911001101110211031104110511061107110811091110111111121113111411151116
- Product Code10275008
- Serial Numbers
163 of 163 codes
102610281029103510401044105210541055105610571058105910601061106210671071107210731074107510761077107810791080108110821083108410851086108710881089109010911092109310941095109610971098109911001101110211031104110511061107110811091110111111131114
- Product Code10275009
- Serial Numbers
232 of 232 codes
101910201021102410261030103110341038103910401041104210431049105010511052105310541055105610571058105910601061106210631065106610671068106910701071107210731074107510761077107810791080108110821083108410851086108710881089109010911092109310941095
- Product Code10275010
- Serial Numbers
288 of 288 codes
100110021003100410051006100710081009101010111012101310141015101610171018101910201021102210231024102510261027102810291030103110321033103410351036103710381039104010411042104310441045104610471048104910501051105210531054105510561057105810591060
- Amount recalled
- 1039 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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