# FDA recall Z-1215-2018

> **Konica Minolta Medical Imaging USA, Inc.** · Class II · device recall initiated 2017-12-04.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1215-2018
- **Recalling firm:** Konica Minolta Medical Imaging USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-04
- **Report date:** 2018-04-04
- **Termination date:** 2019-10-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1215-2018

## Citation

> AI Analytics. FDA recall Z-1215-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1215-2018. Source: US FDA. Licensed CC0.

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