Recall Z-0283-2012 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
| Date | Nov 23, 2011 (initiated Oct 14, 2011) |
| Status | Terminated |
| Reason | Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications version VA60A with Foresight detectors firmware version v1.5.9.12 on the Symbia systems. |
| Root cause | Component change control |
| Action | Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated October 14, 2011 to all affected customers. The letters informed customers of the acquisition software defect in the energy window position when an isotope is peaked, which could potentially impact image interpretation, and that the AEB firmware version on their imaging system has been changed to a previously released version until acquisition software service pack is available. For questions or assistance they were instructed to contact Siemens Medical Solutions USA, Inc. at (800) 888-7436. |
| Quantity | 2 units |
| Distribution | Florida, Illinois and Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082506 | SYMBIA, VERSION 4.0 Siemens Medical Solutions USA, Inc., Nov 21, 2008 |