Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Fiel

FDA device recall Z-1700-2014 · posted 2014-06-03 · Terminated

Recall details

Recalling firm

Hologic, Inc.

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

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.

Root cause

Component change control

Status

Terminated

Product code

MUE

Quantity affected

11 units

Distribution

Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.

Date initiated

2014-05-13

Date posted

2014-06-03

Date terminated

2014-08-18

Location

Danbury, CT