Recall Z-1086-2015 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
| Date | Feb 10, 2015 (initiated Oct 23, 2012) |
| Status | Terminated |
| Reason | There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. |
| Root cause | Component design/selection |
| Action | Consignees were not notified of this issue. |
| Quantity | 719 systems (global) |
| Distribution | Worldwide Distribution-US (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, and WY), and the countries of AUSTRALIA , AUS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041166 | SIEMENS ENHANCED IMAGING SYSTEM Siemens Medical Solutions USA, Inc., May 17, 2004 |