Recall Z-0374-2017— 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: K143416. Product: SOMATOM Definition Flash system, x-ray, tomography, computed. Reason: Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts..
- 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 Flash system, x-ray, tomography, computed
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.