SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
FDA Recall Z-0605-2017 · Posted 2016-11-17
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-10-19
Date Terminated2017-03-13
Product Quantity3077 systems worldwide, 760 systems distributed in the U.S.
Reason for Recall
A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.
Firm Action
Siemens' sent a Customer Safety Advisory Notice letter dated October 19, 2016 to affected customers. The letter identified the affected product, problem, potential risks, how to avoid the potential risk related to this issue and actions to be taken.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.