Recalls / —
—#150604
Product
SOMATOM Definition AS system, x-ray, tomography, computed
- FDA product code
- JAK — System, X-Ray, Tomography, Computed
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K143409
- Affected lot / code info
- Model Numbers: 8098027 10430603
Why it was recalled
Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Siemens mailed a Customer Safety Advisory Notice to affected customers on October 19, 2016, to inform them about the hardware issue. The notice provided guidance on risk prevention and actions they are taking to develop a solution to correct the issue. For further questions, please call (610) 448-6471.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- Nationwide Distribution
Timeline
- Recall initiated
- 2016-10-19
- Posted by FDA
- 2016-11-08
- Terminated
- 2017-03-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #150604. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.