Recall Z-0996-2022— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0996-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-07

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: K200524. Product: syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. 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 record

K200524 — SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GOSiemens Medical Solutions USA, Inc.·cleared 2020-04-01

K-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 SOMATOM go.Sim Model Number 11061660. 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.