Reported Aug 29, 2018 · Ongoing
Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software…
Ortho Kinematics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho Kinematics, Inc · 110 Wild Basin Rd Ste 250 · West Lake Hills, TX · 78746-3352
Is this the product you have?
- Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254
- Product UsageVMA software is a quantitative imaging software application intended to be used to process digital image files
- Lot codes and dates
- 00868579000209.
- Amount recalled
- 1
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed.
This product could cause temporary or reversible health problems — stop using it.
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