Recall Z-2453-2012— Hologic, Inc.

Name: FDA recall Z-2453-2012
Creator: U.S. Food and Drug Administration
Published: 2012-09-14

Class II · Terminated

Class II FDA medical device recall by Hologic, Inc., initiated 2012-09-14, terminated 2014-01-10. It names one FDA 510(k) clearance: K051025. Product: Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.. Reason: Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ around vertical axis as well as 180¿ around a horizontal axis..

Recalling firm: Hologic, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-09-14
Terminated: 2014-01-10
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

Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

Reason for recall

Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ around vertical axis as well as 180¿ around a horizontal axis.

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