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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.
Recalled August 21, 2019 · FDA recall Z-2276-2019 · NeuroLogica
Hazard
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. · FDA Class II
Units
5088 worldwide
Sold at
US Nationwide
Description
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.
Product
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.
Manufacturer(s)
NeuroLogica Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →