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
Check against the official notice below — it lists the full affected range.
NeuroLogica Corporation has recalled its HS70A Diagnostic Ultrasound System across multiple software versions distributed nationwide in the United States. The recall affects approximately 3,582 devices worldwide due to a potential hazard where the ultrasound probes may overheat when a user decreases the Doppler Sample Volume (SV) size value while operating in Doppler Only mode.
The recall involves specific serial numbers and a UDI code, allowing users to identify affected units. However, the recall record does not specify a remedy or recommended corrective action for consumers who possess these devices.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide Quantity: 3582 worldwide Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.