Recall Z-0994-2022— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2022-03-07, terminated 2023-12-19. It names one FDA 510(k) clearance: K211379. Product: syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.. Reason: Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-03-07
- Terminated
- 2023-12-19
- 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
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Reason for recall
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
Data sourced from openFDA. This site is unofficial and independent of the FDA.