FDA-Device2019-08-21Class II
HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12
NeuroLogica Corporation
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.
Sold states
US Nationwide
Affected count
3582 worldwide
Manufactured in
14 Electronics Ave, N/A, Danvers, MA, United States
Products
HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2275-2019Don't want to check this manually?
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