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Recall

Class II — Konica Minolta, Inc.

Recalling firmKONICA MINOLTA, INC.
Registered facilityView this company's 3 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThe Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
ProductDiagnostics Ultrasound System Ultrasounds System Sonimage HS1
Quantity36 units
DistributionCA, CO, KY, FL, NJ, NY, IA TX, & WA
Initiated2017-04-24
Classified2017-07-26
Terminated2018-01-24
Recall numberZ-2769-2017
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Konica Minolta, Inc. (Z-2769-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77712/

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