CLASS II Device recall · Reported 21 Aug 2019 · FDA Enforcement Report
WS80A Diagnostic Ultrasound System recalled by NeuroLogica
NeuroLogica is recalling WS80A Diagnostic Ultrasound System, distributed nationwide in the US. The recall was initiated on 25 Jul 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2276-2019
- FDA event ID
- 83429
- Recalling firm
- NeuroLogica, Danvers, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jul 2019
- FDA classified
- 14 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 25 Jul 2019 | Recall initiated by company | |
| 14 Aug 2019 | Classified by FDA | +20 days |
| 21 Aug 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide
Questions about this recall
Is WS80A Diagnostic Ultrasound System recalled?
Yes. NeuroLogica recalled WS80A Diagnostic Ultrasound System on 25 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2276-2019.
Why was it 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.
Which lots are affected?
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
Where was it sold?
US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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