FDAClass IIApril 4, 2018

Sonimage HS1 Ultrasound Kit AC adapter recall

Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031

Why was Sonimage HS1 Ultrasound Kit AC adapter 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers (each has "A7AP-" prefix): 00045 00041 00004 00076 00090 00016 00037 00038 00060 00059 00091 00028 00089 00080 00077 00039 00057 00040 00007 00043 00024 00071 00003 00064 00011 00052 00027 00006 00044 00042 00063 00078 00087 00047 00031 00048 00008 00068 00095 00103 00096 00098 00097 00099 00100 00101 00102 00082 00084 00092 00083 00069 00079 00061 00019 00072 00081 00051 00018 00017 00065 00055 00053 00012 00015 00073 00023 00074 00002 00075 00066 00094 00020 00070 00056 00049 00025 00085 00093 00046 00086 00022 00009 00010 00021 00013 00014 00029

Product
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
Recalling firm
Konica Minolta Medical Imaging USA, Inc.
Quantity
88
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.
Recall date
April 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls