Data Foundry

Medical device recalls 2018

Sonimage HS1 Ultrasound Kit AC adapter — Class II medical device recall Z-1212-2018

Terminated recall by Konica Minolta Medical Imaging USA, Inc., reported 2018-04-04, distributed in AL, AZ, CA, CO, CT, DC, FL, GA…. There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted

Recall numberZ-1212-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmKonica Minolta Medical Imaging USA, Inc., Wayne, NJ, United States
Recall initiated2017-12-04
Classified2018-03-27
Reported by FDA2018-04-04
Terminated2019-10-28
DistributedAL, AZ, CA, CO, CT, DC, 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
Countries outside the USBR, CA
Quantity88
Reason classesdevice malfunction
UPC / GTIN / UDI-DI04560141940031
Serial numbers00002, 00003, 00004, 00006, 00007, 00008, 00009, 00010, 00011, 00012, 00013, 00014, 00015, 00016, 00017, 00018, 00019, 00020, 00021, 00022, 00023, 00024, 00025, 00027, 00028 and 63 more

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1212-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.