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U.S. Department of Health and Human Services

Class 2 Device Recall Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x

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  Class 2 Device Recall Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x see related information
Date Initiated by Firm September 06, 2013
Date Posted September 30, 2013
Recall Status1 Terminated 3 on December 13, 2013
Recall Number Z-2301-2013
Recall Event ID 66195
PMA Number P010025 
Product Classification Full field digital,system,x-ray,mammographic - Product Code MUE
Product Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x

The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography
Code Information Software versions 5.0.x and 5.1.x
Recalling Firm/
Manufacturer		 Hologic, Inc.
36 Apple Ridge Rd # 37
Danbury CT 06810-7301
For Additional Information Contact
203-207-4500
Manufacturer Reason
for Recall		 Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
FDA Determined
Cause 2		 Software design
Action Hologic sent an Urgent Medical Device Recall letter dated September 5, 2013, by Certified Mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised how to avoid loss of images until Hologic corrects the problem. A software upgrade to customers who are connected to Hologic Connect who have already been connected remotely and customers who have already been connected via a Service Call will receive notification of the problem and the date the system was remotely corrected notified by Certified Mail. A Dealer notification issued by certified mail to inform Dealers of the need to notify their customers of the problem and to correct the identified Selenia system using Hologic Technical Bulletin TB-00072. Selenia software version 5.2 will implement a double safeguard to both guarantee a 28 day retention period, as well as ensure images are removed in a least recently used order. If there are any questions regarding this field correction, please call Hologic Customer Support at 877 371-4372.
Quantity in Commerce 62 systems
Distribution Worldwide Distribution - USA including the states of AL, AR, CA, CO, FL, IL, KY, LA, NE, NC, NJ, NY, OH, PA, TN, TX, UT, WA and WV., and the countries of Canada, Denmark, Iran, Italy, Mexico and Taiwan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MUE and Original Applicant = HOLOGIC, INC.
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