FDA-Device2022-05-25Class II
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Heartware, Inc.
Hazard
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
Sold states
Finland and Turkey
Affected count
510 units
Manufactured in
14400 Nw 60th Ave, N/A, Miami Lakes, FL, United States
Products
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1104-2022Don't want to check this manually?
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