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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PALODEX GROUP OY DIGORA OPTIME; EXTRAORAL SOURCE X-RAY SYSTEM
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PALODEX GROUP OY DIGORA OPTIME; EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number DXR-50
Device Problem Electrical Shorting (2926)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2021
Event Type  malfunction  
Manufacturer Narrative
This issue relates to the 7-8 years old defective power supply unit (psus) of digora optime / scan exam scanners.Fda is aware of the field action and it is covered in recalls z-0839-2020 - z-0842-2020.This is the first report we have received of a user in the united states experiencing this malfunction.This customer had received 3 notifications regarding the field action sent to the dental practice on 08/25/2020, 09/30/2021 and 11/5/2021 and had not yet ordered a replacement psu.The device is being replaced.
 
Event Description
Dental imaging plate scanner device's power supply unit has had a short circuit.Dentist states that there was not a fire but more so the power supply shorting and melting to the inside of the unit.User says no patient was involved, no injury to personnel or property damage occurred.Device is now not functional.
 
Manufacturer Narrative
This issue relates to the 7-8 years old defective power supply unit (psus) of digora optime / scan exam scanners.Fda is aware of the field action and it is covered in recalls z-0839-2020 - z-0842-2020.This is the first report we have received of a user in the united states experiencing this malfunction.This customer had received 3 notifications regarding the field action sent to the dental practice on 08/25/2020, 09/30/2021 and 11/5/2021 and had not yet ordered a replacement psu.The device is being replaced.
 
Event Description
Dental imaging plate scanner device's power supply unit has had a short circuit.Dentist states that there was not a fire but more so the power supply shorting and melting to the inside of the unit.User says no patient was involved, no injury to personnel or property damage occurred.Device is now not functional.
 
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Brand Name
DIGORA OPTIME
Type of Device
EXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
PALODEX GROUP OY
nahkelantie 160
tuusula, uusimaa 04300
FI  04300
Manufacturer (Section G)
PALODEX GROUP OY
nahkelantie 160
tuusula, uusimaa 04300
FI   04300
Manufacturer Contact
eric schwandt
nahkelantie 160
tuusula, uusimaa 04300
FI   04300
MDR Report Key13018602
MDR Text Key285351301
Report Number3005383085-2021-00001
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Dentist
Remedial Action Replace
Type of Report Initial
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDXR-50
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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