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.

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.

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 pallet handle and release button. In the event of touchpad engagement, confirm there are no system errors reported on the PPM and refer to the instructions in the Operator Manual to address proper patient positioning before continuing. If unintended detector motion is observed, downward pressure from the detector is reported by the patient at any time or the PPM presents a system error (as shown in the picture below), then manually retract the patient from the gantry using the patient bed handle and release button, stop use of the system and contact your customer service representative. Errors or problems that result in patient re-scan or re-dose should be reported to your local Siemens Healthiness representative.