Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UD...
FDA Recall #Z-1214-2018 — Class II — December 4, 2017
Product Description
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
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.
Recalling Firm
Konica Minolta Medical Imaging USA, Inc. — Wayne, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
30
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.
Code Information
A9RP Serial Numbers (each has "A9RP-" prefix): 00002 00021 00022 00017 00016 00080 00029 00030 00019 00023 00008 00024 00079 00020 00027 00003 00025 00028 00026; AAEU Serial Numbers (each has "AAEU-" prefix):00001 00016 00017 00018 00019 00020 00021 00022 00023 00024 00025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.