FDA Medical Device Recalls (openFDA)
Konica Minolta Medical Imaging USA, Inc.: Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
- Recall number
- Z-1213-2018
- Recalling firm
- Konica Minolta Medical Imaging USA, Inc.
- Product
- Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
- Status
- Terminated
- Initiated
- 2017-12-04
- Posted
- not on file
- Terminated
- 2019-10-28
- 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.
- Root cause
- Device Design
- Action
- Konica Minolta is preparing for the final AC Adapter replacement. Upon receipt of the new AC Adapter, owners of SONIMAGE HSl System will be asked to replace the existing AC Adapter. Additionally, instructions for the return of the current AC Adapter will be provided.
- Quantity
- 85
- 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.
- Lot, serial or model codes
- Serial Numbers (each has "A8WA-" prefix): 00005 00076 00078 00079 00083 00011 00093 00036 00019 00122 00116 00117 00072 00038 00080 00115 00002 00013 00082 00010 00007 00089 00120 00121 00077 00084 00119 00146 00023 00021 00085 00112 00067 00124 00109 00107 00086 00009 00102 00104 00103 00071 00110 00028 00091 00060 00006 00008 00024 00014 00025 00081 00026 00027 00003 00075 00029 00098 00101 00097 00099 00022 00100 00087 00125 00032 00114 00073 00020 00001 00111 00088 00123 00063 00037 00030 00012 00062 00147 00118 00092 00065 00066 00113 00108
- 510(k) numbers
- ["K152577"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 2241281
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28