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Hologic, Inc. recalls Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System
Recalled May 22, 2013 · FDA recall Z-1326-2013 · Hologic
Hazard
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. · FDA Class II
Units
287
Sold at
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.
Description
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.
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.
Manufacturer(s)
Hologic, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →