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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO., LTD. GC80 DIGITAL DIAGNOSTIC MOBILE X-RAY SYSTEM

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SAMSUNG ELECTRONICS CO., LTD. GC80 DIGITAL DIAGNOSTIC MOBILE X-RAY SYSTEM Back to Search Results
Model Number GC80
Device Problems Computer Software Problem (1112); Display or Visual Feedback Problem (1184)
Patient Problem Unintended Radiation Exposure (4565)
Event Date 10/19/2021
Event Type  malfunction  
Event Description
The customer reported that they could not obtain all required images, and they had to re-expose a (b)(6) patient.
 
Manufacturer Narrative
After performing a scan, the user was unable to obtain all required images. The field service engineer visited the site and determined that the software version had software bugs, which caused the error. The software was downgraded to ensure this issue did not re-occur. As the patient was only re-exposed one additional time, there is low risk to any incident or harm. The re-exposure was well below threshold of concern. Service tickets will be reviewed to ensure no trend is seen for similar issues.
 
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Brand NameGC80
Type of DeviceDIGITAL DIAGNOSTIC MOBILE X-RAY SYSTEM
Manufacturer (Section D)
SAMSUNG ELECTRONICS CO., LTD.
129, samsung-ro
yeongtong-gu
suwon-si, gyeonggido 16677
KS 16677
MDR Report Key12847931
MDR Text Key285564939
Report Number3004938766-2021-00016
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGC80
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/19/2021
Distributor Facility Aware Date10/19/2021
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer11/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

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