FDA Medical Device Recalls (openFDA)
Konica Minolta, Inc.: Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
- Recall number
- Z-2769-2017
- Recalling firm
- Konica Minolta, Inc.
- Product
- Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
- Status
- Terminated
- Initiated
- 2017-04-24
- Posted
- not on file
- Terminated
- 2018-01-24
- Reason
- The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
- Root cause
- Software design
- Action
- Konica Minolta notified their customers on April 24, 2017.
- Quantity
- 36 units
- Distribution
- CA, CO, KY, FL, NJ, NY, IA TX, & WA
- Lot, serial or model codes
- UDI 04560141940031 04560141944534 04560141945463 04560141946385 V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)
- 510(k) numbers
- ["K142197","K152577","K162065"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 2241281
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28