Sonimage HS1 Ultrasound Kit AC adapter — Class II medical device recall Z-1214-2018
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 number | Z-1214-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Konica Minolta Medical Imaging USA, Inc., Wayne, NJ, United States |
| Recall initiated | 2017-12-04 |
| Classified | 2018-03-27 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2019-10-28 |
| Distributed | AL, 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 US | BR, CA |
| Quantity | 30 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04560141945463, 04560141945470, 04560141946385 |
| Serial numbers | 00002, 00003, 00008, 00016, 00017, 00018, 00019, 00020, 00021, 00022, 00023, 00024, 00025, 00026, 00027, 00028, 00029, 00030, 00079, 00080 |
Product
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.
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-1214-2018. 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.