Reported Aug 21, 2019 · Terminated
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,…
NeuroLogica Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NeuroLogica Corporation · 14 Electronics Ave · Danvers, MA · 01923-1011
Is this the product you have?
- 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
- Lot codes and dates
- UDI08806167789220
- Serial Numbers
S1C0M3HK300004AS1C0M3HK300005PS1C0M3HK300006DS1C0M3HK300007XS1C0M3HK300008NS1C0M3HK300001KS1C0M3HK300002ZS1C0M3HK400005ZS1C0M3HK400006YS1C0M3HK400008PS1C0M3HK400001LS1C0M3HK400002TS1C0M3HK400003BS15NM3HK200005NS15NM3HK100001XS1C0M3HKC00001HS1C0M3HKC00002JS1C0M3HK900001ZS1C0M3HK900002YS1C0M3HK900003AS1C0M3HK900004PS1C0M3HK900005DS1C0M3HK900006XS1C0M3HK900007NS1C0M3HK900008ES1C0M3HK900009FS1C0M3HK900010LS1C0M3HK900011TS1C0M3HK800001PS1C0M3HK800002DS1C0M3HK700001NS1C0M3HK700002E
- Amount recalled
- 3582 worldwide
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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