Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Bug
Ortho Kinematics, Inc. is recalling VMA DataLink Software versions 2.3.231 and 2.3.232 because a software bug caused erroneous test results.
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 situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any injuries or illnesses, and the issue is a software bug causing erroneous results rather than a direct physical hazard, fitting the Moderate category for a voluntary precautionary recall of a medical device software.
Plain-English summary
Ortho Kinematics, Inc. has issued a recall for the Vertebral Motion Analyzer (VMA) DataLink Software, specifically versions 2.3.231 and 2.3.232. The recall is due to a software bug that resulted in erroneous VMA test results. The product is a quantitative imaging software application intended to process digital image files.
The recall covers units distributed nationwide in the United States. Ortho Kinematics, Inc. has notified customers regarding the issue and has corrected the software bug. The source text does not specify the number of affected units or report any specific injuries or illnesses associated with the erroneous results.
Customers who have purchased or are using these specific software versions should contact Ortho Kinematics, Inc. for further instructions on how to obtain the corrected software.
The recalled product
- Product
- Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: 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)
- 00868579000209
Distribution
Distributed nationwide across the United States.
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