Data Foundry

Medical device recalls 2019

SOMATOM go — Class II medical device recall Z-2399-2019

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-09-04, distributed nationwide. The injector holder could potentially fall off together with the injector and the storage box.

Recall numberZ-2399-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated2019-07-31
Classified2019-08-27
Reported by FDA2019-09-04
Terminated2020-12-02
DistributedNationwide (US)
Quantity0
Model numbers11061610, 11061618

Product

SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data

Reason for recall

The injector holder could potentially fall off together with the injector and the storage box.

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-2399-2019. 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.