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Terminated

SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system

FDA Recall Z-2624-2016 · Posted 2016-08-23

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-07-13
Date Terminated2017-01-24
Product Quantity1 unit

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.

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