Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device 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.
Reported: September 9, 2020 Initiated: August 14, 2020 #Z-2934-2020
Product Description
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device 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.
Reason for Recall
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc.
- Units Affected
- 412 units
- Distribution
- US Nationwide distribution including in the states of Alabama, Alaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wisconsin.
- Location
- Hoffman Estates, IL
Frequently Asked Questions
What product was recalled? ▼
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device 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.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 412 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 9, 2020. Severity: Moderate. Recall number: Z-2934-2020.
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