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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM; FULL FILED DIGITAL MAMMOGRAPHY SYSTEM
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HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM; FULL FILED DIGITAL MAMMOGRAPHY SYSTEM Back to Search Results
Model Number SDM-SYS-6000-2D
Device Problem Poor Quality Image (1408)
Patient Problem Not Applicable (3189)
Event Date 12/22/2017
Event Type  malfunction  
Event Description
It was reported that they are getting artifacts in the biopsy images, causing the patient to be re-exposed.It was determined that some of the image processing parameters needed to be changed.Once this was done the unit is working as intended.
 
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Brand Name
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
Type of Device
FULL FILED DIGITAL MAMMOGRAPHY SYSTEM
Manufacturer (Section D)
HOLOGIC, INC.
36 & 37 apple ridge road
danbury CT 06810
Manufacturer Contact
debra rosenberg
36 & 37 apple ridge road
danbury, CT 06810
2032074512
MDR Report Key7207682
MDR Text Key97910100
Report Number1220984-2018-00080
Device Sequence Number1
Product Code MUE
UDI-Device Identifier15420045505636
UDI-Public15420045505636
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PO10025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Radiologic Technologist
Type of Report Initial
Report Date 12/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Radiologic Technologist
Device Model NumberSDM-SYS-6000-2D
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
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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