Z-2275-2019Class II

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...

Name: Z-2275-2019 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...
Creator: NeuroLogica Corporation
Published: 2019-07-25
License: https://open.fda.gov/license/

Samsung HME America, Inc. / initiated 2019-07-25 / Terminated / root cause: software

FDA source

NeuroLogica Corporation began a recall of 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... on 2019-07-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2275-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-25
Posted: 2019-08-14
Terminated: 2020-09-11
Recalling firm: Samsung HME America, Inc.
Product: 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
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: software
FDA root cause: Software design
Action: 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].
Quantity in commerce: 3582 worldwide
Distribution: US Nationwide
Product codes and lots: UDI: 08806167789220 Serial Numbers: S1C0M3HK300004A S1C0M3HK300005P S1C0M3HK300006D S1C0M3HK300007X S1C0M3HK300008N S1C0M3HK300001K S1C0M3HK300002Z S1C0M3HK400005Z S1C0M3HK400006Y S1C0M3HK400008P S1C0M3HK400001L S1C0M3HK400002T S1C0M3HK400003B S15NM3HK200005N S15NM3HK100001X S1C0M3HKC00001H S1C0M3HKC00002J S1C0M3HK900001Z S1C0M3HK900002Y S1C0M3HK900003A S1C0M3HK900004P S1C0M3HK900005D S1C0M3HK900006X S1C0M3HK900007N S1C0M3HK900008E S1C0M3HK900009F S1C0M3HK900010L S1C0M3HK900011T S1C0M3HK800001P S1C0M3HK800002D S1C0M3HK700001N S1C0M3HK700002E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2275-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2275-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-14
Z-2276-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-14

Product code IYN

K173713Class IIHS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. / cleared 2018-03-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)