Z-1215-2018 Class II Terminated

Recalled by Konica Minolta Medical Imaging USA, Inc. — Wayne, NJ

Recall Details

Product Type
Devices
Report Date
April 4, 2018
Initiation Date
December 4, 2017
Termination Date
October 28, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17

Product Description

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

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.

Distribution Pattern

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.

Code Information

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