Recall Z-0116-2015 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
| Date | Oct 22, 2014 (initiated Oct 28, 2013) |
| Status | Terminated |
| Reason | Reports of loose bolts in the detector support structure of Symbia and e.cam systems. |
| Root cause | Process control |
| Action | Undated "Customer Safety Advisory Notice" letters were sent to all direct accounts (customers). The letters stated the problem, and included instructions for customers. Customers: 1) can continue to use the devices while waiting for an inspection to be scheduled and performed; and, 2) their local service engineer will inspect the detector pivot connections and make any necessary repairs on site. Customers with any questions can contact their local service representative or Siemens Molecular Imaging at 800-888-7436. |
| Quantity | 4,862 devices |
| Distribution | Worldwide Distribution -- USA, including the states of AK, AL, 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, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the District of Columbia, Guam, and |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952109 | IP500 NUCLEAR GAMMA CAMERA SYSTEM Siemens Medical Solutions USA, Inc., Aug 23, 1995 |