NeuroLogica Corporation: 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.

Agency Publication Date: August 14, 2019

Affected Products

Product: 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

UDI: 08806167789220 Serial Numbers: S1C0M3HK300004A S1C0M3HK300005P S1C0M3HK300006D S1C0M3HK300007X S1C0M3HK300008N S1C0M3HK300001K S1C0M3HK300002Z S1C0M3HK400005Z S1C0M3HK400006Y S1C0M3HK400008P S1C0M3HK400001L S1C0M3HK400002T S1C0M3HK400003B S15NM3HK200005N S15NM3HK100001X S1C0M3HKC00001H S1C0M3HKC00002J S1C0M3HK900001Z S1C0M3HK900002Y S1C0M3HK900003A S1C0M3HK900004P S1C0M3HK900005D S1C0M3HK900006X S1C0M3HK900007N S1C0M3HK900008E S1C0M3HK900009F S1C0M3HK900010L S1C0M3HK900011T S1C0M3HK800001P S1C0M3HK800002D S1C0M3HK700001N S1C0M3HK700002E

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.

UDI: 08806167780081 Serial Numbers: S116M3HJ600006V S116M3HJ600002H S116M3HJ400012W S116M3HJ400013V S18EM3HJA00002B S18EM3HK900002Y S18EM3HK800001P S18EM3HJB00003L S18EM3HJB00004T S18EM3HJB00005B S116M3HJ600008T S116M3HJ500005T S18EM3HJB00001W S18EM3HJB00002V S18EM3HJB00006K S18EM3HJA00003K S18EM3HJ900017P S18EM3HJ900018D S18EM3HK800005E S18EM3HK700012D S1B1M3HK100001X S18EM3HK700011P S18EM3HK700013X S18EM3HK700007M S18EM3HK700009V S18EM3HK700010A S18EM3HK700005H S18EM3HK700006J S18EM3HK700001N S18EM3HK700003F S18EM3HK700004R S18EM3HK900001Z S18EM3HK900003A S18EM3HK900005D S18EM3HK700008W S18EM3HK800002D S18EM3HK800003X S18EM3HK800004N S116M3HJ500004L S18EM3HJA00001T S18EM3HK900006X S18EM3HK900007N S18EM3HK900008E S18EM3HK900009F S18EM3HK900010L S18EM3HKC00001H S18EM3HKC00002J S18EM3HK900004P S18EM3HK800006F S18EM3HK700002E S18EM3HM500009Y S18EM3HM500010F S18EM3HM500011R S18EM3HM500012H S18EM3HM500007K S18EM3HM500008Z S18EM3HM500001M S18EM3HM500002W S18EM3HM500003V S18EM3HM500004L S18EM3HM500005T S18EM3HM500006B S18EM3HM400001L

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83429

Status: Resolved

Manufacturer: NeuroLogica Corporation

Manufactured In: United States

Units Affected: 2 products (3582 worldwide; 5088 worldwide)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: 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