Recall Z-0914-2015 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 588keV.
| Date | Jan 6, 2015 (initiated Apr 8, 2014) |
| Status | Terminated |
| Reason | There is a potential for patient finger injury on the e.cam systems. |
| Root cause | Use error |
| Action | The firm, Siemens, sent a "Customer Safety Advisory Notice" letter dated April 8, 2014 to all direct accounts (customers). The letter described the product, problem and actions to be taken. The letter instructed the customers to follow the instructions in the e.cam operator's manual and the e.cam Patient Bed Safety Addendum of the operator's manual; and to always monitor the patient at all times while they are on the system during initiation of any system movement. The letter further requested that customers forward the letter to the new owner of the equipment in the event that the system is |
| Quantity | 4,462 systems |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY and Puerto Rico; and countries of: Algeria , Angola , Argentina , Austra |
| FDA record | Open on fda.gov |