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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
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HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM Back to Search Results
Model Number SDA-SYS-3000-2D-HTC
Device Problem Unintended System Motion (1430)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
Event Type  malfunction  
Event Description
It was reported that during a procedure the c-arm switch caused incorrect or unexpected movement.No injury reported.A field engineer was dispatched to the site and determined the rear rotational switch needed to be replaced.Once this was completed the system was working as intended.
 
Event Description
It was reported that during a procedure the c-arm switch caused incorrect or unexpected movement.No injury reported.A field engineer was dispatched to the site and determined the rear rotational switch needed to be replaced.Once this was completed the system was working as intended.
 
Manufacturer Narrative
The rotation switch was returned to hologic for further investigation.Functional check determined that the switch was performing as intended.A review of the complaint history showed no recurring similar events.A definitive root cause cannot be established since there was no malfunction found.Hologic strives for continuous improvement and will continue to monitor and trend for safety.
 
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Brand Name
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
Type of Device
FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Manufacturer (Section D)
HOLOGIC, INC
36 & 37 apple ridge road
danbury CT 06810
Manufacturer Contact
kristin fornieri
36 & 37 apple ridge road
danbury, CT 06810
2037318491
MDR Report Key13017964
MDR Text Key285841551
Report Number1220984-2021-00055
Device Sequence Number1
Product Code MUE
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P010025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/16/2021
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 NumberSDA-SYS-3000-2D-HTC
Device Catalogue NumberSDA-SYS-3000-2D-HTC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2021
Initial Date Manufacturer Received 11/22/2021
Initial Date FDA Received12/16/2021
Supplement Dates Manufacturer Received11/22/2021
Supplement Dates FDA Received01/13/2022
Was Device Evaluated by Manufacturer? Yes
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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