Recall Z-1558-2016 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
| Date | Apr 22, 2016 (initiated Apr 1, 2016) |
| Status | Terminated |
| Reason | The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected). There is also a risk of a potential misdiagnosis in using this protocol for surgery planning. Investigations revealed an incorrect parameterization of the reconstruction algorithm applied for the pediatric head kernel as cause of the problem. |
| Root cause | Software design |
| Action | Siemens distributed a Safety Advisory Notice dated April 1, 2016, to affected customers The letter identified the affected product, problem, how to avoid potential risks, how the issue will be resolved. and actions to be taken. Customers were asked to observe the safety notice and comply with the corresponding measures until further notice. |
| Quantity | 37 CTsystems |
| Distribution | US Nationwide Distribution : NC, NH, IL, MA, WA, PA, MD, MN, TX, NY, SC, OH, CA, KY, MT, IA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133589 | SOMATOM FORCE Siemens Medical Solutions USA, Inc., Apr 17, 2014 |