Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1214-2018 — Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470

U.S. FDA — Device Enforcement · United States · 2017-12-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1214-2018
Date of alert
2017-12-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Konica Minolta Medical Imaging USA, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04560141945463
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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