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
- Company
- Neurologica Corporation
- Recall Initiated
- July 25, 2019
- Terminated
- September 11, 2020
- Recall Number
- Z-2275-2019
- Quantity
- 3582 worldwide
- Firm Location
- Danvers, MA
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.
Distribution
US Nationwide
Lot / Code Info
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
Root Cause
Software design
Action Taken
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 tleinart@neurologica.com.