Recall Z-0604-2017— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-10-19, terminated 2017-03-13. It names one FDA 510(k) clearance: K143400. Product: SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash 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.. Reason: 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-19
- Terminated
- 2017-03-13
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.