RecallRadar

FDA Device recall Z-1215-2018

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

On 2018-04-04 the FDA classified a Class II recall of Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588 by Konica Minolta Medical Imaging Usa, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1215-2018
ClassificationClass II
Statusterminated
Initiated2017-12-04
Published2018-04-04
Last updated2026-09-13 11:54 UTC
CompanyKonica Minolta Medical Imaging Usa
DistributionAL, AZ, CA, CO, CT, DC, 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

Product

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

Reason

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.

Identifiers

code_infoSerial Numbers (each has "A8AR-" prefix): 00068 00031 00062 00066 00063 00047 00065 00032 00064 00028 00069 00060 00027 00067 00061 00001 00002

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1215-2018%22

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