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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA LTD VERSA HD; ACCELERATOR, LINEAR, MEDICAL
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ELEKTA LTD VERSA HD; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Device Problems Product Quality Problem (1506); Material Integrity Problem (2978)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.Previously submitted in error as 9617016-2021-00000 on 29/04/2021.Re-submitted on 29/04/2021 as 9617016-2021-00003.
 
Event Description
Elekta have raised an internal case to assess the risk of crosswire screen flammability on all beam limiting devices.
 
Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The crosswire screen base material has a ul-94-hb rating, but the effects of the additional primers, coatings and silk screen are not known.There are multiple causal factors involved in a crosswire screen catching alight and the probability of this happening has been assessed as implausible.The severity has been assessed as moderate which is within the acceptable region.
 
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Brand Name
VERSA HD
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
ELEKTA LTD
linac house
fleming way
crawley, RH10 9RR
UK  RH10 9RR
MDR Report Key11745137
MDR Text Key263494304
Report Number9617016-2021-00003
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
PMA/PMN Number
K192242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Date Manufacturer Received03/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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