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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEDECAL SEDECAL X-RAY GENERATOR

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SEDECAL SEDECAL X-RAY GENERATOR Back to Search Results
Model Number SHF835
Device Problems Energy Output Problem (1431); Radiation Output Problem (4026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2018
Event Type  malfunction  
Event Description
Excessive x-ray (photon particles) of 8 mrem.
 
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Brand NameSEDECAL
Type of DeviceX-RAY GENERATOR
Manufacturer (Section D)
SEDECAL
c / pelaya, 9 - 13, pol. ind.
algete, spain 28110
SP 28110
Manufacturer Contact
walter moore
2000 edmund halley drive
reston, VA 20191
5714494992
MDR Report Key10430601
MDR Text Key204590600
Report Number3000256071-2018-70001
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
12345
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Remedial Action Repair
Type of Report Initial
Report Date 09/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSHF835
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/13/2018
Device Age3 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer09/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/20/2020 Patient Sequence Number: 1
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