Recall Z-2435-2015 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.
| Date | Aug 20, 2015 (initiated Jul 31, 2015) |
| Status | Terminated |
| Reason | Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly. |
| Root cause | Component change control |
| Action | Siemens has sent an undated Customer Advisory Notice letter to all direct accounts (customers). The letters include instructions for customers to: 1) Continue to use the system(s) while waiting for the field correction to be scheduled and performed unless the user observes a burning smell or sees evidenve of smoke. the user should engage the emergency stop, power down and discontinue use of the system, and contact the local service representative. 2) Ensure that this advisory is placed in the system's instructions for use. Siemens reminds the user to observe the patient during studies. 3) If t |
| Quantity | 1183 Systems |
| Distribution | Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and Internationally to Algeria, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142006 | SYMBIA 6.0 Siemens Medical Solutions USA, Inc., Aug 21, 2014 |