Recall Z-0093-2018 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System 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. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imag
| Date | Nov 7, 2017 |
| Status | Terminated |
| Reason | The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered. |
| Root cause | Software design |
| Action | Siemens Healthineers sent a Customer Safety Advisory Notice Letter to each impacted consignee beginning on November 07, 2017. Depending on the customer's capabilities, Siemens provides the letters via mail, e-mail, or hand delivery by a service engineer. The receipt of the letter will be documented and additional attempts will be made until such receipt is acknowledged. Certified mail will be used to track the submission of the letter. Certified mail receipts will be obtained for each customer. Adobe e-signature will be obtained from the customers receiving the Customer Advisory Letter via |
| Quantity | 2 units |
| Distribution | Worldwide Distribution to Malaysia, France, Japan, Reunion Island |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162337 | Symbia 6.5 Siemens Medical Solutions USA, Inc., Sep 8, 2016 |