Diagnostics Ultrasound System Ultrasounds System Sonimage HS1 — Class II medical device recall Z-2769-2017
Terminated recall by Konica Minolta, Inc., reported 2017-08-02, distributed in CA, CO, FL, IA, KY, NJ, NY, TX…. The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
| Recall number | Z-2769-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Konica Minolta, Inc., Wayne, NJ, United States |
| Recall initiated | 2017-04-24 |
| Classified | 2017-07-26 |
| Reported by FDA | 2017-08-02 |
| Terminated | 2018-01-24 |
| Distributed | CA, CO, FL, IA, KY, NJ, NY, TX, WA |
| Quantity | 36 units |
| UPC / GTIN / UDI-DI | 04560141940031, 04560141944534, 04560141945463, 04560141946385 |
Product
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Reason for recall
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
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-2769-2017. 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.