Sonimage HS1 Ultrasound Kit AC adapter — Class II medical device recall Z-1215-2018
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-1215-2018 |
|---|---|
| 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 | 17 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04560141941588 |
| Serial numbers | 00001, 00002, 00027, 00028, 00031, 00032, 00047, 00060, 00061, 00062, 00063, 00064, 00065, 00066, 00067, 00068, 00069 |
Product
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
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-1215-2018. 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.