The Recall Desk
HighFDA (Devices)·Z-1326-2013·Announced 2013-05-22

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

Hologic is recalling Fluoroscan Mini C-arm InSight systems because the audible alarm for cumulative irradiation time is inaccurate. This may result in incorrect total irradiation time readings.

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 medical device with a defect that affects the accuracy of irradiation time monitoring, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Hologic, Inc. is recalling 287 units of the Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, and 3.x. The device is a Mini C-arm Fluoroscopic Imaging System used for general fluoroscopic visualization, including surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging.

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 is not accurate. This inaccuracy may affect the monitoring of patient exposure during procedures.

The affected devices were distributed worldwide, including the United States (nationwide) and countries such as Germany, Russia, Australia, Italy, Great Britain, Spain, France, South Korea, South Africa, Canada, Argentina, Lithuania, Taiwan, China, Belgium, Austria, Japan, Qatar, Saudi Arabia, Singapore, Hong Kong, Slovenia, Netherlands, and Sweden. Users should contact Hologic, Inc. for instructions on how to address the software inaccuracy.

The recalled product

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
Manufacturer
Hologic, Inc.
Category
Medical Device — Fluoroscopic Imaging System
Hazard
Affected units
287

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

Same manufacturer · Hologic, Inc.

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