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WS80A Diagnostic Ultrasound System Version 1.00.16… recallZ-2276-2019 · NeuroLogica Corporation · initiated Jul 25, 2019

Class II Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from NeuroLogica Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Software design

What the company is doing

On July 25, 2019, Neurological Corporation a subsidiary of Samsung Electronics issued Urgent Field Safety Notices to customers. Customers were advised to the following actions: 1) If the user wants to decrease the Dopper SV (Sample Volume) size set by himself/herself in the Doppler Only Mode, the user should press "set" button to update the PW Doppler mode. 2) A copy of the Field Safety Notice should be passed on to all who need to be aware within your organization. 3) Contact your local Samsung representative if you have questions. 4) Return the completed Customer Reply Form to Tom Leinart [email protected].

Recall details

Recall number
Z-2276-2019
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 25, 2019
Recalling firm
NeuroLogica Corporation
Quantity
5088 worldwide
Product code
IYN
FDA submissions
K153529, K173513
Distribution
US Nationwide

Product 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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 83429).

Sources and updates

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