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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D

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HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D Back to Search Results
Model Number SDM-SYS-9000-3D
Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem Not Applicable (3189)
Event Date 10/02/2017
Event Type  malfunction  
Event Description
It was reported that they are getting intermittent artifacts in the image causing the patient to be re-exposed.The artifact was able to be pixel mapped out and once the system was rebooted, it is working as intended.
 
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Brand Name
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D
Type of Device
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
MDR Report Key6991266
MDR Text Key91220538
Report Number1220984-2017-00117
Device Sequence Number1
Product Code OTE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PO80003
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 10/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Radiologic Technologist
Device Model NumberSDM-SYS-9000-3D
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 Received10/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
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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