Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Report Error
Ortho Kinematics is recalling the Vertebral Motion Analyzer (VMA) software because a bug caused errors in the Radiological Read Report.
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 2/5 (Moderate).
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, which typically indicates a temporary or medically reversible adverse health consequence. The source describes a software bug causing report errors without mentioning specific injuries or hospitalizations, fitting the Moderate category for low-risk contamination or minor errors.
Plain-English summary
Ortho Kinematics, Inc. is recalling the Vertebral Motion Analyzer (VMA), version 2.3.250, a radiological image processing system. The recall is due to a software bug that resulted in errors within the Radiological Read Report for VMA tests.
The affected product was distributed nationwide in the United States. The source text does not specify the number of units affected or the specific nature of the report errors beyond stating that an error was contained in the report.
Consumers and healthcare providers should contact Ortho Kinematics, Inc. for further instructions regarding the corrected software and the impact on previous test reports.
The recalled product
- Product
- Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
- Manufacturer
- Ortho Kinematics, Inc
- Hazard
- 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)
- 00868579000209
Distribution
Distributed nationwide across the United States.
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