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U.S. Department of Health and Human Services

Class 2 Device Recall Hologic Selenia Full Field Digital Mammography System

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 Class 2 Device Recall Hologic Selenia Full Field Digital Mammography Systemsee related information
Date Initiated by FirmMay 13, 2014
Date PostedJune 03, 2014
Recall Status1 Terminated 3 on August 18, 2014
Recall NumberZ-1700-2014
Recall Event ID 68298
PMA NumberP010025 
Product Classification Full field digital,system,x-ray,mammographic - Product Code MUE
ProductHologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
Code Information Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W 
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		Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
FDA Determined
Cause 2		Component change control
ActionHologic notified customers by letter dated 5/13/14 via certified mail or Federal Express to inform customers of the problem and provide acknowledgement of the notification and confirmation that their systems have been corrected A Dealer notification dated 5/13/14 sent by certified mail or Federal Express 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-00806. On 5/16/14 the firm expanded the recall to an additional units Mammography System M-IV (2 units) and Selenia Mammography Systems (4) by letter dated 5/14/14. If there are any questions regarding this field correction, please call Hologic Customer Support at 877 371-4372.
Quantity in Commerce11 units
DistributionDistributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = MUE
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