WS80A Diagnostic Ultrasound System Version 1 recalled over fire hazard

Recall date

July 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

NeuroLogica Corporation recalls WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01…

Recall number

Z-2276-2019

FDA classification

Class II

Brand / firm

NeuroLogica Corporation

Sold / distributed

US Nationwide

Why it was recalled

There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07, 4.01.08, 4.01.09.