Recall Z-1701-2014— Hologic, Inc.

Name: FDA recall Z-1701-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-13

Class II · Terminated

Class II FDA medical device recall by Hologic, Inc., initiated 2014-05-13, terminated 2014-08-18. It names one FDA 510(k) clearance: K011987. 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.. Reason: 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.

Recalling firm: Hologic, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-13
Terminated: 2014-08-18
Firm location: Danbury, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K011987 — MODIFIED M-IV MAMMOGRAPHY SYSTEMLorad, A Hologic Co.·cleared 2001-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.