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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 Problems Poor Quality Image (1408); Calibration Problem (2890)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
As of today, the investigation is still in-process.A follow-up will be filed as needed.
 
Event Description
It was reported that during contrast procedures where a lesion is present, there is no evidence of the lesion in the contrast images.No patient impact reported.
 
Event Description
The k-factor values were updated by the field engineer and the affected images were reprocessed.Once this was completed the system was working as intended.
 
Event Description
The k calibration data from the system was evaluated by an imaging scientist and it was determined that the k-factor values needed to be updated.
 
Manufacturer Narrative
As of today the investigation is still in-process.A supplement will be filed as needed.
 
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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
MDR Report Key7778728
MDR Text Key117165843
Report Number1220984-2018-00132
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 company representative,foreig
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSDM-00001-2D
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number1220984-11/27/18-001-C
Patient Sequence Number1
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