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.
FDA Recall Z-2276-2019 · Posted None
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Recalling FirmNeuroLogica Corporation
Recall StatusTerminated
Product CodeIYN
Date Initiated2019-07-25
Date Terminated2020-09-11
Product Quantity5088 worldwide
Reason for Recall
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.
Firm Action
On July 25, 2019, Neurological Corporation a subsidiary of Samsung Electronics issued Urgent Field Safety Notices to customers.
Customers were advised to the following actions:
1) If the user wants to decrease the Dopper SV (Sample Volume) size set by himself/herself in the Doppler Only Mode, the user should press "set" button to update the PW Doppler mode.
2) A copy of the Field Safety Notice should be passed on to all who need to be aware within your organization.
3) Contact your local Samsung representative if you have questions.
4) Return the completed Customer Reply Form to Tom Leinart [email protected].
Root Cause
Software design
Distribution Pattern
US Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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