Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Error
Ortho Kinematics is recalling Vertebral Motion Analyzer (VMA) software version 2.3.252 due to a software bug that caused errors in released testing results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software bug corrected via a notice of correction without reporting any injuries, illnesses, or specific adverse health consequences, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho Kinematics, Inc. is recalling Vertebral Motion Analyzer (VMA) software, version 2.3.252. This quantitative imaging software application is intended to process digital image files. The recall involves one unit distributed nationwide in the United States.
The recall was initiated because the company sent a Notice of Correction to Released Testing Results and Radiological Read Reports for the VMA test. The source text states that these reports contained an error resulting from a software bug, which has since been corrected.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take beyond the correction of the software bug.
The recalled product
- Product
- Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
- Manufacturer
- Ortho Kinematics, Inc
- Category
- Medical Device — Software
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00868579000209
Distribution
Distributed nationwide across the United States.
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