FDA-Device2024-10-30Class II
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Blue Ortho
Hazard
Predict+ is being recalled for lack of pre-market clearance/approval.
Sold states
US Nationwide distribution.
Affected count
136 software units
Manufactured in
22 Chemin Du Vieux Chene, N/A, Meylan, N/A, France
Products
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0209-2025Don't want to check this manually?
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