FDA recall Z-1215-2018

Konica Minolta Medical Imaging USA, Inc. · Class II · device

Product

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

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.

Key facts

Status: Terminated
Initiation date: 2017-12-04
Report date: 2018-04-04
Termination date: 2019-10-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1215-2018