Orthoscan Mobile Mini C-arm System Recalled for 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 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 involves a medical device with a software defect that could lead to unintended radiation exposure (risk-of-harm product). No injuries or illnesses are reported in the source text, which aligns with 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) due to a software non-conformity. The defect allows a user to activate the Digital Zoom feature while taking a live image, which exposes a larger x-ray field than can be viewed by the user.
The affected devices were distributed worldwide, including the United States (nationwide, Puerto Rico, and Hawaii) and numerous international markets. The recall was initiated after Orthoscan discovered the non-conformity during an investigation of a non-standard workflow.
The source text does not specify specific corrective actions for consumers or healthcare providers, such as whether the devices should be removed from service or if a software patch is available. Users should contact Orthoscan, Inc. for specific instructions regarding the affected serial numbers.
The recalled product
- Product
- Mobile Mini C-arm system Part # 1000-0004. 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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