Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2452-2012 — 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, critic

U.S. FDA — Device Enforcement · United States · 2012-09-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2452-2012
Date of alert: 2012-09-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Hologic, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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