The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2453-2012·Announced 2012-10-03

Hologic Fluoroscan Mini C-Arm Software Recall for Image Orientation Errors

Hologic is recalling Fluoroscan Mini C-Arm devices with specific InSight software versions because DICOM images may be flipped 180 degrees when stored in PACS systems.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states no illnesses or injuries are reported. The hazard is a software defect affecting image orientation, which fits the criteria for a moderate severity recall involving low-risk contamination or minor errors without reported harm.

Plain-English summary

Hologic, Inc. is recalling Fluoroscan Mini C-Arm models equipped with InSight- FD Software Version 5.0.1 and 5.0.2. The recall involves 46 units distributed worldwide, including the United States and various international markets. The device is a Mini C-arm Fluoroscopic Imaging System designed for general fluoroscopic visualization, including surgical orthopedic and podiatry use.

The recall is due to a software defect where DICOM images stored in Picture Archiving and Communication Systems (PACS) may be flipped 180 degrees around the vertical axis. Additionally, for the InSight FD versions 5.0.1 and 5.0.2, images may also be flipped 180 degrees around the horizontal axis. This orientation error could affect the accuracy of the stored medical images.

Healthcare facilities and users of these specific software versions should contact Hologic, Inc. for further instructions on how to resolve the issue. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 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…
Manufacturer
Hologic, Inc.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
46

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)

  • Software version 5.0.1and 5.0.2

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 →

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