The Recall Desk
HighFDA (Devices)·Z-0258-2018·Announced 2018-01-17

Orthoscan Mobile Mini C-arm System Recalled for Software Defect

Orthoscan is recalling 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 is visible to the user.

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, and the hazard involves a risk of harm (excessive x-ray exposure) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Orthoscan, Inc. is recalling 2,012 Mobile Mini C-arm systems (Part # 1000-0001) worldwide. The 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 in the device software during an investigation of a non-standard workflow. The defect allows a user to activate the Digital Zoom feature while taking a live image, which exposes a larger x-ray field than the user can view.

The affected units were distributed in the United States (including Puerto Rico and Hawaii) and in numerous countries including Australia, Canada, Germany, Japan, and the United Kingdom. Specific serial numbers are listed in the agency's recall record. Users should contact Orthoscan, Inc. for instructions on how to resolve the software issue.

The recalled product

Product
Mobile Mini C-arm system Part # 1000-0001. 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.

See all →