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.
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 3/5 (High).
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 defect that poses a risk of harm (unintended radiation exposure) but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
OrthoScan, Inc. is recalling 2,012 Mobile Mini C-arm systems (Part # 1000-0005) under FDA recall number Z-0260-2018. 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 markets. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any specific injuries or illnesses associated with the defect.
The recalled product
- Product
- Mobile Mini C-arm system Part # 1000-0005. 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.
- Affected units
- 2,012
Distribution
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.
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