Fluoroscan Mini C-arm InSight — Class II medical device recall Z-1326-2013
Terminated recall by Hologic, Inc., reported 2013-05-22, distributed nationwide. The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate
| Recall number | Z-1326-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., Bedford, MA, United States |
| Recall initiated | 2013-04-25 |
| Classified | 2013-05-16 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2014-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 287 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1326-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.