Hologic, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2453-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 14, 2012

Date Posted: October 3, 2012

Recall Number: Z-2453-2012

Event ID: 63180

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.

Status: Terminated

Product Quantity: 46 units

Code Information:

Software version 5.0.1and 5.0.2

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia,Belgium, Canada, China, Germany, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Italy, Japan Korea, Lithuvania, Neherlands, qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan, South Africa, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated