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Terminated

SOMATOM Definition Flash system, x-ray, tomography, computed

FDA Recall Z-0374-2017 · Posted 2016-11-08

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-10-19
Date Terminated2017-03-13
Product Quantity57 systems distributed in USA

Reason for Recall

Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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