Hologic Fluoroscan Mini C-Arm Model with InSight2 — Class II medical device recall Z-2452-2012
Terminated recall by Hologic, Inc., reported 2012-10-03, distributed nationwide. InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight
| Recall number | Z-2452-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., Bedford, MA, United States |
| Recall initiated | 2012-09-14 |
| Classified | 2012-09-25 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2014-01-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, CA, CH, CN, DE, EC, ES, FR, GB, GR, HK, IT, JP, KR, QA, RU, SA, SE, SG, SI, TH, TW, ZA |
| Quantity | 414 units |
Product
Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 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
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.
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-2452-2012. 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.