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.
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 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.
- 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.
See all 4 products in this recall →Related recalls
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