Recall Z-0061-2017 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Symbia S, Product Usage 1) SPECT: 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. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axi
| Date | Aug 16, 2013 |
| Status | Terminated |
| Reason | The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. |
| Root cause | Component design/selection |
| Action | Customers were contacted by a service organization that performed product inspections at their sites. |
| Quantity | 732 units |
| Distribution | Worldwide Distribution - US: Nationwide, including Washington D.C., and Puerto Rico. and the countries of: Poland, France, Austria, Czech Republic, Ireland, Germany, Italy, Japan, Canada, United Arab Emirates, Turkey, Netherlands, United Kingdom, Brazil, South Africa, Kuwait, Belgium, Russia, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041166 | SIEMENS ENHANCED IMAGING SYSTEM Siemens Medical Solutions USA, Inc., May 17, 2004 |