FDA Device recall Z-1214-2018
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463 by Konica Minolta Medical Imaging Usa, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1214-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-04 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Konica Minolta Medical Imaging Usa |
| Distribution | 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 |
Product
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
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.
Identifiers
| code_info | A9RP Serial Numbers (each has "A9RP-" prefix): 00002 00021 00022 00017 00016 00080 00029 00030 00019 00023 00…A9RP Serial Numbers (each has "A9RP-" prefix): 00002 00021 00022 00017 00016 00080 00029 00030 00019 00023 00008 00024 00079 00020 00027 00003 00025 00028 00026; AAEU Serial Numbers (each has "AAEU-" prefix):00001 00016 00017 00018 00019 00020 00021 00022 00023 00024 00025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1214-2018%22
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