The Recall Desk
HighFDA (Devices)·Z-0261-2018·Announced 2018-01-17

OrthoScan Recalls Mobile Mini C-arm Systems Due to Software Defect

OrthoScan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than visible.

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 is classified as FDA Class II. The hazard involves a software defect that exposes a larger x-ray field than visible, creating a risk of unintended radiation exposure. No injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

OrthoScan, Inc. is recalling 2,012 Mobile Mini C-arm systems (Part # 1000-0004-FD) under FDA recall number Z-0261-2018. These devices are intended to provide physicians with general fluoroscopic visualization for surgical orthopedic and critical care procedures.

The recall was initiated after OrthoScan discovered a non-conformity during an investigation of a non-standard workflow. The system software allows a user to activate the Digital Zoom feature while taking a live image. This action exposes a larger x-ray field than can be viewed by the user, potentially leading to unintended radiation exposure.

The affected units were distributed worldwide, including the United States (nationwide, Puerto Rico, and Hawaii) and numerous international locations such as Australia, Canada, Germany, Japan, and the United Kingdom. A complete list of affected serial numbers is available in the source documentation. Users should contact OrthoScan, Inc. for instructions on how to resolve the software issue.

The recalled product

Product
Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
Manufacturer
Orthoscan, Inc.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
2,012

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Orthoscan, 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 4 products in this recall →

Related recalls

Same manufacturer · Orthoscan, Inc.

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Same hazard · radiation exposure

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