Drug recall
Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging…
FDA recall event 80771 · Class II · Ortho Kinematics, Inc
Key facts
| Event ID | 80771 |
|---|---|
| Recall numbers | Z-2891-2018 |
| Recalling firm | Ortho Kinematics, Inc |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Mar 2, 2017 |
| Report date | Aug 29, 2018 |
| City | West Lake Hills |
| State | TX |
| Country | United States |
| FEI number | 3006172536 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: