Recall Z-1297-2015 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
E.CAM 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.
| Date | Mar 19, 2015 (initiated Apr 11, 2012) |
| Status | Terminated |
| Reason | Radial motor drives replaced during a customer service action were incorrectly assembled backwards. |
| Root cause | Employee error |
| Action | Urgent Field Correction- Recall letters dated April 11, 2012 were sent to all potentially affected customers. The letters included instructions for customers to immediately remove the patient from the bed and contact the customer's Service Engineer in the event that one of the following errors is displayed "A motion control error has occurred (E112)" or "A motion control error has occurred (E113)." Customers were advised that a Service Engineer will be inspecting the radial drive gear on the customer's camera system to ensure it is functioning correctly and that the machines can continue to be |
| Quantity | 4,856 systems (worldwide) |
| Distribution | Worldwide Distribution-US (nationwide) including the District of Columbia and the states of 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, VA, VT, WA, WI, and WV and the countries |
| 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 |