CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report

Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA recalled

Konica Minolta Medical Imaging USA is recalling Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, distributed in 35 states. The recall was initiated on 4 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled85

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1213-2018
FDA event ID: 79455
Recalling firm: Konica Minolta Medical Imaging USA, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 4 Dec 2017
FDA classified: 27 Mar 2018
Reported: 4 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

4 Dec 2017	Recall initiated by company
27 Mar 2018	Classified by FDA	+113 days
4 Apr 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 79455

This product is part of a recall event; the main page for the event is Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR recalled.

Reported	Class	Recall	Company	Reason	Where
4 Apr 2018	CLASS II	Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR recalled	Konica Minolta Medical Imaging USA	Device Malfunction	35 states
4 Apr 2018	CLASS II	Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A9RP recalled	Konica Minolta Medical Imaging USA	Device Malfunction	35 states
4 Apr 2018	CLASS II	Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP recalled	Konica Minolta Medical Imaging USA	Device Malfunction	35 states

More recalls from Konica Minolta Medical Imaging USA

All 6

Reported	Class	Recall	Company	Reason	Where
4 Jul 2018Device	CLASS II	ImagePilot, Model No. D9MA recalled by Konica Minolta Medical	Konica Minolta Medical Imaging USA	Device Malfunction	Nationwide
4 Jul 2018Device	CLASS II	CS-7, Model No. A4C1 recalled by Konica Minolta Medical	Konica Minolta Medical Imaging USA	Device Malfunction	Nationwide
4 Apr 2018Device	CLASS II	Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP recalled	Konica Minolta Medical Imaging USA	Device Malfunction	35 states
4 Apr 2018Device	CLASS II	Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A9RP recalled	Konica Minolta Medical Imaging USA	Device Malfunction	35 states
4 Apr 2018Device	CLASS II	Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR recalled	Konica Minolta Medical Imaging USA	Device Malfunction	35 states

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