Reported Oct 30, 2024 · Ongoing
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of…
Blue Ortho
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: Blue Ortho · 22 Chemin Du Vieux Chene · Meylan, N/A · N/A
Is this the product you have?
- Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
- Lot codes and dates
- Software version v1.3
- Amount recalled
- 136 software units
Where it was sold
- Nationwide
Why it was recalled
Predict+ is being recalled for lack of pre-market clearance/approval.
This product could cause temporary or reversible health problems — stop using it.
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