Data Foundry

Medical device recalls 2021

syngo — Class II medical device recall Z-2446-2021

Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2021-09-22, distributed nationwide. Potential for data loss when using the contouring or patient marking workflow when editing a structure set aft

Recall numberZ-2446-2021
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated2021-08-16
Classified2021-09-10
Reported by FDA2021-09-22
DistributedNationwide (US)
Quantity44 systems
Serial numbers108085, 112045, 112071, 112261, 117756, 119216, 128015, 128016, 128018, 128019, 128020, 128022, 128029, 128033, 128035, 128039, 128041, 128045, 128046, 128049, 128051, 128057, 128060, 128063, 128065 and 32 more

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 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).

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2446-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.