Recall Z-2898-2020 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
E.cam or Symbia systems that use foresight detectors - Product Usage: 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 | Mar 31, 2016 |
| Status | Terminated |
| Reason | 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 diff |
| Root cause | Software design |
| Action | Based on the results of our risk assessment indicating that the probability of occurrence is remote, you may continue to use your system. Please ensure that this advisory is placed in the system's instructions for use. To reduce the likelihood of this issue, perform Daily Shutdown and Start-up as described in the operator manual. If you have sold this equipment and it is no longer in your possession, we kindly ask that you forward this notice to the new owner of this equipment. Please inform us about the new owner of the equipment. Adverse events or quality problems experienced with the use |
| Quantity | 5,066 systems. |
| Distribution | US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142006 | SYMBIA 6.0 Siemens Medical Solutions USA, Inc., Aug 21, 2014 |