The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2452-2012·Announced 2012-10-03

Hologic Fluoroscan Mini C-Arm Recalled for Flipped DICOM Images

Hologic is recalling Fluoroscan Mini C-Arm devices with InSight2 software versions 4.0 and 4.0.1 because DICOM images stored in PACS may be flipped 180 degrees.

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 hazard involves a software defect causing image orientation errors without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Hologic, Inc. is recalling 414 units of the 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 surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situations.

The recall is due to a software defect where DICOM images stored in the Picture Archiving and Communication System (PACS) may be flipped 180 degrees around the vertical axis. This issue affects the specific software versions listed in the recall notice.

The affected devices were distributed worldwide, including the United States (nationwide) and numerous international locations such as Argentina, Australia, Belgium, Canada, China, Germany, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Italy, Japan, Korea, Lithuania, Netherlands, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan, South Africa, and Switzerland. Healthcare facilities should contact Hologic for instructions on how to resolve the software issue.

The recalled product

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…
Manufacturer
Hologic, Inc.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
414

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 4.0 and 4.0.1

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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