Recall Z-2934-2020 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
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.
| Date | Aug 14, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | On 8/14/20 the firm notified their customers via letter of the field action, with the following instructions: How can you help to avoid the potential risk of this issue? You may continue to use your system ensuring to follow all instructions in the Operator Manual. Do not leave the patient unattended at any time while the patient is positioned on the patient bed. Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road Hoffman Estates, IL 60192 USA In the event of an Emergency-Stop, shutdown or power loss the patient should be manually retracted from the gantry using the patient bed palle |
| Quantity | 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 Car |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200474 | Symbia 6.7 Siemens Medical Solutions USA, Inc., Mar 20, 2020 |