Recall Z-1214-2018 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Konica Minolta Medical Imaging USA, Inc.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
| Date | Dec 4, 2017 |
| Status | Terminated |
| 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 | 30 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162065 | Ultrasound System SONIMAGE HS1 Konica Minolta, Inc., Oct 19, 2016 |