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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
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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 06/16/2021
Event Type  malfunction  
Event Description
It was reported that the c-arm continued to move down after the footswitch was released.No injury reported.A field engineer was dispatched to the site and the footswitch was replaced.Once this was completed the system was working as intended.
 
Manufacturer Narrative
The reported foot switch was returned to hologic for evaluation.Visual evaluation identified minor wear due to multiple number of usages.Functional evaluation was performed and the reported event could not be duplicated.The foot switch functioned as intended.A definitive root cause cannot be determined at this time.Hologic 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
MDR Report Key12144172
MDR Text Key263527779
Report Number1220984-2021-00022
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 07/09/2021
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 NumberSDM-00001-2D
Device Catalogue NumberSDM-00001-2D
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/16/2021
Initial Date FDA Received07/09/2021
Supplement Dates Manufacturer Received06/16/2021
Supplement Dates FDA Received10/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2011
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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