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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2021
Event Type  malfunction  
Event Description
It was reported that when using the left footswitch the c-arm continued moving.No injury reported.A field engineer was dispatched to the site and determined the footswitch needed to be replaced.Once that was completed the system was working as intended.
 
Manufacturer Narrative
The reported footswitch was returned to hologic for investigation and a functional evaluation was performed.It was determined that the c-arm switch was functioning as per the operating specification.The reported issue could not be duplicated.The footswitch was installed with the system in (b)(6) 2009.Additionally, it was also noted that the compression switch was detached from the c-arm switch, potentially due to transit damage.
 
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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 06810
MDR Report Key11845789
MDR Text Key252243061
Report Number1220984-2021-00010
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 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
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? Yes
Date Manufacturer Received04/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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