Recall Z-1521-2016— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-03-02, terminated 2016-12-13. It names one FDA 510(k) clearance: K120579. Product: Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.. Reason: Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-02
- Terminated
- 2016-12-13
- 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
Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Reason for recall
Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.
Data sourced from openFDA. This site is unofficial and independent of the FDA.