Hologic, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1326-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 25, 2013

Date Posted: May 22, 2013

Recall Number: Z-1326-2013

Event ID: 65028

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.

Status: Terminated

Product Quantity: 287

Code Information:

Serial numbers per recall strategy.

Distribution Pattern:

Worldwide distribution: USA (nationwide) and countries of: DE, RU, AU, IT, GB, ES, FR, KR, ZA, CA, AR, LT, TW, CN, BE, AT, JP, QA, SA, SG, HK, SI, NL, and SE.

Voluntary or Mandated:

Voluntary: Firm initiated