Recall Z-0911-2015 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by
| 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 | 877 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 |