Z-1213-2018Class II

Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534

Name: Z-1213-2018 Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
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: A8WA, UDI: 04560141944534 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-1213-2018
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: A8WA, UDI: 04560141944534
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: 85
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 "A8WA-" prefix): 00005 00076 00078 00079 00083 00011 00093 00036 00019 00122 00116 00117 00072 00038 00080 00115 00002 00013 00082 00010 00007 00089 00120 00121 00077 00084 00119 00146 00023 00021 00085 00112 00067 00124 00109 00107 00086 00009 00102 00104 00103 00071 00110 00028 00091 00060 00006 00008 00024 00014 00025 00081 00026 00027 00003 00075 00029 00098 00101 00097 00099 00022 00100 00087 00125 00032 00114 00073 00020 00001 00111 00088 00123 00063 00037 00030 00012 00062 00147 00118 00092 00065 00066 00113 00108

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1213-2018
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

K152577Class IIUltrasound System Sonimage Hs 1Konica Minolta, Inc. / cleared 2015-10-08

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)