Recall Z-1326-2013— Hologic, Inc.

Name: FDA recall Z-1326-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-25

Class II · Terminated

Class II FDA medical device recall by Hologic, Inc., initiated 2013-04-25, terminated 2014-08-21. It names one FDA 510(k) clearance: K051025. Product: Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.. Reason: The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate..

Recalling firm: Hologic, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-04-25
Terminated: 2014-08-21
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K051025 — FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEMHologic, Inc.·cleared 2005-05-13

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

Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

Reason for recall

The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.

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