Hologic, Inc. recalls Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screenin

Recalled June 11, 2014 · FDA recall Z-1701-2014 · Hologic

Hazard

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 Class II

Units

3 units

Sold at

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

Description

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

Product

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

Manufacturer(s)

Hologic, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →