Recall Z-1940-2018— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-04-20, terminated 2019-05-23. It names one FDA 510(k) clearance: K163296. Product: SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.. Reason: There is a potential for a software issue that may cause the need for necessary patient rescans..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-20
- Terminated
- 2019-05-23
- 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 Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
Reason for recall
There is a potential for a software issue that may cause the need for necessary patient rescans.
Data sourced from openFDA. This site is unofficial and independent of the FDA.