Z-1212-2018Class II

Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031

Name: Z-1212-2018 Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
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: A7AP, UDI: 04560141940031 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-1212-2018
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: A7AP, UDI: 04560141940031
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: 88
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 "A7AP-" prefix): 00045 00041 00004 00076 00090 00016 00037 00038 00060 00059 00091 00028 00089 00080 00077 00039 00057 00040 00007 00043 00024 00071 00003 00064 00011 00052 00027 00006 00044 00042 00063 00078 00087 00047 00031 00048 00008 00068 00095 00103 00096 00098 00097 00099 00100 00101 00102 00082 00084 00092 00083 00069 00079 00061 00019 00072 00081 00051 00018 00017 00065 00055 00053 00012 00015 00073 00023 00074 00002 00075 00066 00094 00020 00070 00056 00049 00025 00085 00093 00046 00086 00022 00009 00010 00021 00013 00014 00029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1212-2018
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

K142197Class IIUltrasound System Sonimage Hs1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc. / cleared 2014-11-21

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)