Recall Z-1700-2014

Hologic, Inc. · initiated May 13, 2014

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Hologic 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.

Codes / lots: Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W

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: Component change control

Action taken

Hologic 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.

Details

Recall number
Z-1700-2014
Initiated
May 13, 2014
Posted by FDA
June 3, 2014
Terminated
August 18, 2014
Product code
MUE – Full Field Digital, System, X-Ray, Mammographic
Quantity
11 units
Distribution
Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Recalling firm
Hologic, Inc., Danbury, CT

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1701-2014 Class IIHologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic…Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the… 05/13/2014Terminated