Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Report Errors
Ortho Kinematics is recalling VMA software versions 2.3.239 through 2.3.254 because administrative errors caused incorrect data in radiological and VMA reports.
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, which typically indicates a moderate risk. The source describes an administrative error leading to report inaccuracies, which fits the criteria for moderate severity without evidence of direct physical injury or high-risk pathogens.
Plain-English summary
Ortho Kinematics, Inc. is recalling the Vertebral Motion Analyzer (VMA) software, versions 2.3.239 through 2.3.254. The software is a quantitative imaging application used to process digital image files. The recall covers one unit distributed nationwide in the United States.
The recall was initiated because errors were found in the Radiological Read Report and VMA Report generated by the software. According to the source text, these errors resulted from an administrative error in VMA user account settings. The manufacturer states that the error has been fixed.
Customers who use this software should be aware that previous reports may contain incorrect data. Users should verify the accuracy of their reports and contact Ortho Kinematics for further instructions on how to proceed with the corrected software.
The recalled product
- Product
- Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. 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
- 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.
Related recalls
Same manufacturer · Ortho Kinematics, Inc
See all →- ModerateOrtho Kinematics Recalls Vertebral Motion Analyzer Software Due to Report Error
FDA (Devices) · 2018-08-29
- ModerateOrtho Kinematics Recalls Vertebral Motion Analyzer Software Due to Error
FDA (Devices) · 2018-08-29
- ModerateOrtho Kinematics Recalls Vertebral Motion Analyzer Software Due to Bug
FDA (Devices) · 2018-08-29
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02