SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
FDA Recall Z-2626-2016 · Posted 2016-08-23
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-07-13
Date Terminated2017-01-24
Product Quantity4 systems
Reason for Recall
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.
Firm Action
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.
Root Cause
Software in the Use Environment
Distribution Pattern
Distributed to: MI, NY, CA, KY, ND, NE
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.