—#148570

Product

SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K143401
Affected lot / code info: Model # 8098027 Serial # 96020, 96047, 96011, and 96029

Why it was recalled

Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.

Root cause (FDA determination)

Software in the Use Environment

Action the firm took

Siemens mailed to customers an Important Customer Safety Notice to inform about a possible malfunction when using the affected systems and what actions to take to eliminate the problem. Also, Siemens informed their customers that they were currently developing a new firmware to eliminate the internal communication error, which should be released in August 2016. Customers were asked to contact their service organization at 800-888-7436, if they had any questions.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Distributed to: MI, NY, CA, KY, ND, NE

Timeline

Recall initiated: 2016-07-13
Posted by FDA: 2016-08-23
Terminated: 2017-01-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148570. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.