Hologic, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1701-2014)

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 M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

Product Classification:

Class II

Date Initiated: May 13, 2014

Date Posted: June 11, 2014

Recall Number: Z-1701-2014

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: 3 units

Code Information:

Serial Numbers: 1800314 7263, 180031472, 18002023051PR

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