Data Foundry

Medical device recalls 2021

syngo — Class II medical device recall Z-2445-2021

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-2445-2021
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)
Quantity126 units
Serial numbers100418, 100419, 100420, 100421, 100641, 100642, 100643, 100644, 100645, 100677, 100713, 100811, 100812, 100813, 100814, 101724, 101773, 102021, 102031, 102108, 102113, 102305, 102369, 130125, 130140 and 104 more

Product

syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

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-2445-2021. 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.