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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 SDM-00001-2D
Device Problem Unintended System Motion (1430)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2022
Event Type  malfunction  
Event Description
It was reported that the c-arm continued rotating passed 45 degrees to 155 degrees.No injuries were reported.A field engineer is being dispatched to site, and investigation is still in progress.
 
Event Description
It was determined that the rotation switch needed to be replaced.Once that was completed the system was left working as intended.
 
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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
evelyn lopez
36 & 37 apple ridge road
danbury, CT 06810
MDR Report Key14112278
MDR Text Key289283345
Report Number1220984-2022-00024
Device Sequence Number1
Product Code MUE
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P010025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSDM-00001-2D
Device Catalogue NumberSDM-00001-2D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2013
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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