Reported Jan 14, 2015 · Terminated
The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting,…
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 Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures
- SPECTThe SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology)
- using the following techniquesplanar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588 keV
- CTThe CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes taken at different angles. SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patients physiological (SPECT) and anatomical (CT) images
- SoftwareThe syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT, and other imaging modalities
- Lot codes and dates
- 1)
- Symbia TProduct
- Number10275007
- Serial Numbers
393 of 393 codes
100310051006100710081009101010111012101310141015101610171018101910201021102210231024102510261027102810291030103110321033103410351036103710381039104010411042104310441045104610471048104910501051105210531054105510561057105810601061106210631064
- Product Number10275008
- Serial Numbers
210 of 210 codes
100110021003100410051006100710081009101010111012101310141015101610171018101910201021102210231024102510261028102910301031103210331035103610371038103910401041104210441045104610471048104910501051105210531054105510561057105810591060106110621063
- Product Number10257009
- Serial Numbers
253 of 253 codes
100110021003100410051006100710081009101010111012101310141015101610171018101910201021102210231024102510261027102810291030103110321033103410361037103810391040104110421043104410451046104710481049105010511052105310541055105610571058105910601061
- Product Number10275010
- Serial Numbers
272 of 272 codes
100110021003100410051006100710081009101010111012101310141015101610171018101910201021102210231024102510261027102810291030103110321033103410351036103710381039104010411042104310441045104610471048104910501051105210531054105510561057105810591060
- Product Number8717733
- Serial Numbers
205 of 205 codes
100010021003100410051006100710081009101010111012101310141015101610171018101910201021102210231024102510261027102810291030103210331034103510361037103810391040104110421043104410451046104810491050105110521053105410551056105710581059106010611062
- Amount recalled
- 1330 systems
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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