Z-1215-2018Class II

Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588

Name: Z-1215-2018 Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
Creator: Konica Minolta Medical Imaging USA, Inc.
Published: 2017-12-04
License: https://open.fda.gov/license/

Konica Minolta, Inc. / initiated 2017-12-04 / Terminated / root cause: design

FDA source

Konica Minolta Medical Imaging USA, Inc. began a recall of Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588 on 2017-12-04. FDA classified it as Class II and gives the reason as "There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1215-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-04
Posted: 2018-03-27
Terminated: 2019-10-28
Recalling firm: Konica Minolta, Inc.
Product: Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
Root cause tag: design
FDA root cause: Device Design
Action: Konica Minolta is preparing for the final AC Adapter replacement. Upon receipt of the new AC Adapter, owners of SONIMAGE HSl System will be asked to replace the existing AC Adapter. Additionally, instructions for the return of the current AC Adapter will be provided.
Quantity in commerce: 17
Distribution: Distributed in the following U.S. states: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI and the District of Columbia. Distributed in Canada and Brazil.
Product codes and lots: Serial Numbers (each has "A8AR-" prefix): 00068 00031 00062 00066 00063 00047 00065 00032 00064 00028 00069 00060 00027 00067 00061 00001 00002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1215-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1212-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1213-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1214-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1215-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27

Product code IYN

K151060Class IIUltrasound System SONIMAGE HS1Konica Minolta, Inc. / cleared 2015-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)