🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: July 25, 2019 NeuroLogica Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
NeuroLogica Corporation
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2276-2019

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