Recall Z-2446-2021— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2446-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-16

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2021-08-16. It names one FDA 510(k) clearance: K200524. Product: syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670. Reason: Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS)..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-08-16
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.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670

Reason for recall

Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

Data sourced from openFDA. This site is unofficial and independent of the FDA.