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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC SELENIA MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
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HOLOGIC, INC SELENIA MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM Back to Search Results
Model Number SEL-00007
Device Problem Unintended System Motion (1430)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/27/2020
Event Type  malfunction  
Event Description
It was reported that the vta bearing was worn causing c-arm movement.No injury reported.A field engineer was dispatched to the site and determined that the vta needed to be replaced.Once this was completed the system was working as intended.
 
Manufacturer Narrative
The on-site investigation found the vta unit badly worn and gearing no longer meshing together when rotating.The field engineer's resolution was to replace the vta unit.The machine was recalibrated and functioned within hologic's specifications.Further investigation of the component revealed the failure mechanism was due to the bearings used within the device reaching the average life expectancy limit.It should also be noted that this type of failure would not result in un-commanded motion in the vertical travel direction.
 
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Brand Name
SELENIA MAMMOGRAPHY SYSTEM
Type of Device
FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Manufacturer (Section D)
HOLOGIC, INC
36 & 37 apple ridge road
danbury, ct
MDR Report Key9991620
MDR Text Key189454201
Report Number1220984-2020-00048
Device Sequence Number1
Product Code MUE
Combination Product (y/n)N
PMA/PMN Number
P010025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSEL-00007
Device Catalogue NumberSEL-00007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2020
Initial Date Manufacturer Received 03/27/2020
Initial Date FDA Received04/23/2020
Supplement Dates Manufacturer Received03/27/2020
Supplement Dates FDA Received08/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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