Reported Sep 2, 2020 · Terminated
E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of…
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 · 60192-2061
Is this the product you have?
- E.cam or Symbia systems that
- use foresight detectors - Product UsageTo 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
- Lot codes and dates
- Model Numbers
87177338717741102750071027500910275010106076491076480110764802107648031076480410275879104130094380213438022152428265977066597707459840055989079598908759890955991109599111759920997324143776093277611617823920782393878239467823953782397910151531101515321052074510607648. E
- Cam series serial numbers
182 of 182 codes
80158061RC49380058660866986898687872387081078109310941104110811121207117511065116231007100399658149120351301005106910731074100710761080108110821095100910981010109910111109101611361137113911501151115210191155115411631026116711741176118611871188
- Symbia series serial numbers
1,266 of 1,266 codes
Serial No 100110021008100110071348101210011014100914331011101514821018100710031004100810231011102410261028102910131038100810151009101110121013101510161040104510171019101810491022103410251056102610381027105810281029103010251027102810311032103910341038
- Model Numbers
- Amount recalled
- 5,066 systems.
Where it was sold
Why it was recalled
E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis indicates that the probability of occurrence is remote. 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.
This product could cause temporary or reversible health problems — stop using it.
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