Recall Z-0913-2015 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantifi
| Date | Jan 6, 2015 (initiated Aug 12, 2014) |
| Status | Terminated |
| Reason | Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries. |
| Root cause | Device Design |
| Action | Siemens sent Customer Safety Advisory Notice letters to all customers of record. The letters instructed customers to: 1) continue to use their system(s); 2) place the safety advisory in the system's instructions for use; and, 3) to anticipate that their local service engineer will contact them to perform an inspection and schedule any necessary repairs by December 2014. Customers were also instructed to share the letter with their support staff and, if the equipment was sold or transferred, to forward the safety notice to the new owner of the equipment. Customers with questions can contact t |
| Quantity | 6 systems |
| Distribution | Worldwide Distribution - USA (naitonwide) and Internationally to Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131634 | SYMBIA Siemens Medical Solutions USA, Inc., Aug 16, 2013 |