FDA Device recall Z-2769-2017
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
- FDA Device
- Class II
- terminated
- Published 2017-08-02
On 2017-08-02 the FDA classified a Class II recall of Diagnostics Ultrasound System Ultrasounds System Sonimage HS1 by Konica Minolta, citing the Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2769-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-24 |
| Published | 2017-08-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Konica Minolta |
| Distribution | CA, CO, FL, IA, KY, NJ, NY, TX, WA |
Product
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Reason
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
Identifiers
| code_info | UDI 04560141940031 04560141944534 04560141945463 04560141946385 V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2769-2017%22
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