Reported Sep 9, 2020 · Terminated
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the…
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?
- Symbia S-Series
- and Symbia T-Series - Product UsageIntended
- use of the device SPECTTo 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
8717741871773310275007102750081027500910275010
- Serial Numbers
218 of 218 codes
105410751124101912351230100210191105113512171158102610371081112811651013100910491050106710771144115011511179119112101247107411491202118010171018105510481080113111731176100812031077107610791095111512151152100110461055110911841236100110921160
- Model
- Amount recalled
- 412 units
Where it was sold
Why it was recalled
This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk.
This product could cause temporary or reversible health problems — stop using it.
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