Recall Z-1721-2014 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
| Date | Jun 4, 2014 (initiated Mar 21, 2014) |
| Status | Terminated |
| Reason | The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury. |
| Root cause | Component design/selection |
| Action | Siemens sent a Customer Safety Advisory Notice/ Field Safety Notice letter dated March 21, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that the system modification would be implemented by Siemens service specialists in April 2014 to correct the problem. |
| Quantity | 345 |
| Distribution | US Nationwide Distribution in the states of IA, TX, FL, NE, NY, OH, NC, KS, IL, CA, OK including PR. |
| FDA record | Open on fda.gov |