The Recall Desk
HighFDA (Devices)·Z-1327-2013·Announced 2013-05-22

Hologic Fluoroscan Mini C-arm InSight2 Recalled for Inaccurate Irradiation Time Alarms

Hologic is recalling Fluoroscan Mini C-arm InSight2 systems because the audible alarm and total cumulative irradiation time displays are inaccurate.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (radiation exposure) where the safety alarm is inaccurate, but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products without reported injury.

Plain-English summary

Hologic, Inc. is recalling the Fluoroscan Mini C-arm InSight2, a Mini C-arm Fluoroscopic Imaging System, in software versions 3.x, 4.0, 4.0.1, and 4.0.2. The recall involves 2,780 units distributed worldwide, including the United States and various international markets.

The recall is due to a defect where the audible alarm that alerts the operator when cumulative irradiation time reaches five minutes is not accurate. Additionally, the total cumulative irradiation time displayed by the device is not accurate. This device is designed to provide physicians with general fluoroscopic visualization for surgical orthopedic, podiatry, critical, and emergency procedures.

Healthcare facilities and users should contact Hologic, Inc. for instructions on how to address the software inaccuracy. The source text does not specify a specific action for consumers, as the product is a professional medical device.

The recalled product

Product
Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 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,
Manufacturer
Hologic, Inc.
Category
Medical Device — Fluoroscopic Imaging System
Hazard
Affected units
2,780

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial numbers per recall strategy.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Hologic, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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Same hazard · radiation exposure

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