Reported Aug 21, 2019 · Terminated
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,…
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?
- 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.
- Lot codes and dates
- UDI08806167780081
- Serial Numbers
63 of 63 codes
S116M3HJ600006VS116M3HJ600002HS116M3HJ400012WS116M3HJ400013VS18EM3HJA00002BS18EM3HK900002YS18EM3HK800001PS18EM3HJB00003LS18EM3HJB00004TS18EM3HJB00005BS116M3HJ600008TS116M3HJ500005TS18EM3HJB00001WS18EM3HJB00002VS18EM3HJB00006KS18EM3HJA00003KS18EM3HJ900017PS18EM3HJ900018DS18EM3HK800005ES18EM3HK700012DS1B1M3HK100001XS18EM3HK700011PS18EM3HK700013XS18EM3HK700007MS18EM3HK700009VS18EM3HK700010AS18EM3HK700005HS18EM3HK700006JS18EM3HK700001NS18EM3HK700003FS18EM3HK700004RS18EM3HK900001ZS18EM3HK900003AS18EM3HK900005DS18EM3HK700008WS18EM3HK800002DS18EM3HK800003XS18EM3HK800004NS116M3HJ500004LS18EM3HJA00001TS18EM3HK900006XS18EM3HK900007NS18EM3HK900008ES18EM3HK900009FS18EM3HK900010LS18EM3HKC00001HS18EM3HKC00002JS18EM3HK900004PS18EM3HK800006FS18EM3HK700002ES18EM3HM500009YS18EM3HM500010FS18EM3HM500011RS18EM3HM500012HS18EM3HM500007KS18EM3HM500008ZS18EM3HM500001MS18EM3HM500002WS18EM3HM500003VS18EM3HM500004L
- Amount recalled
- 5088 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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