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Recall Observatory FDA recall evidence

Device product

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

Z-1215-2018

December 04, 2017

Class II

Product summary

Firm
Konica Minolta Medical Imaging USA, Inc.
Event
Event 79455
Status
Terminated
Classification
Class II
Quantity
17
Official record key
device-enforcement:Z-1215-2018

Official wording

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.

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.