Hologic, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1700-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 13, 2014

Date Posted: June 11, 2014

Recall Number: Z-1700-2014

Event ID: 68298

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

Status: Terminated

Product Quantity: 11 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated