Recall Z-2275-2019 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
NeuroLogica Corporation
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
| Date | Jul 25, 2019 |
| Status | Terminated |
| Reason | 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 | 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 To |
| Quantity | 3582 worldwide |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173713 | HS70A Diagnostic Ultrasound System Samsung Medison Co., Ltd., Mar 8, 2018 |