Recall Z-2042-2014 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device.
| Date | Jul 11, 2014 (initiated Apr 23, 2014) |
| Status | Terminated |
| Reason | Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose. |
| Root cause | Device Design |
| Action | A Customer Safety Advisory Notice dated April 23, 2014 was sent to every direct account. The letter included instructions for direct accounts to discontinue use of the collimator cart and notify the local service representative if they notice or suspect tha one or more casters are loose (which would be indicated by shaking while the cart is in motion). Otherwise, a service representative will be contacting the direct account within the following 3 months to schedule a retention bracket installation. Direct accounts with questions can contact Siemens Medical Solutions USA, Inc. at 800-888-7436. |
| Quantity | 2,458 systems |
| Distribution | Worldwide Distribution- US: Nationwide (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 ; WY) + District |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131634 | SYMBIA Siemens Medical Solutions USA, Inc., Aug 16, 2013 |