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U.S. Department of Health and Human Services

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

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SAMSUNG ELECTRONICS CO., LTD. GC80 DIGITAL DIAGNOSTIC 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  
Manufacturer Narrative
The investigation is ongoing and not yet completed. The risk assessment will be reviewed during investigation.
 
Event Description
The customer reported that they could not obtain all required images, and they had to re-expose a (b)(6) patient.
 
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Brand NameGC80
Type of DeviceDIGITAL DIAGNOSTIC X-RAY SYSTEM
Manufacturer (Section D)
SAMSUNG ELECTRONICS CO., LTD.
129, samsung-ro, yeongtong-gu
suwon-si, gyeonggido 16677
KS 16677
Manufacturer (Section G)
SAMSUNG ELECTRONICS CO., LTD.
129, samsung-ro yeongtong-gu
suwon-si, gyeonggido 16677
KS 16677
Manufacturer Contact
jeongwoo kim
129, samsung-ro yeongtong-gu
suwon-si, gyeonggido 16677
KS   16677
MDR Report Key12850267
MDR Text Key281104901
Report Number3010300212-2021-00007
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGC80
Device Catalogue Number515CM3HJ100001L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/23/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/19/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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