FDAMay 23, 2018device
Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.
What to do
FDA enforcement status: Ongoing
Brands named
ortho kinematicsortho
UPCs
00868579000209
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAVITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.2025-07-29
- FDAChemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.2025-07-29
- FDAVITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;2025-07-09
- FDAVITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.2025-06-12
- FDABrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/...2025-06-10
- FDAVITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);2025-06-10
- FDABrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/...2025-06-10
- FDAVITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);2025-06-10
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