FDA Recall
Open, Classified
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Recall: Z-0209-2025
·
Initiated August 30, 2024
Recall
- Recall Number
- Z-0209-2025
- Event Number
- 95322
- Firm
- Blue Ortho 22 Chemin Du Vieux Chene Meylan France
- FEI Number
- 3008027912
- Product Code
- N/A
- Status
- Open, Classified
- Root Cause
- No Marketing Application
- Initiated
- August 30, 2024
- Posted
- October 24, 2024
Description
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Reason
Predict+ is being recalled for lack of pre-market clearance/approval.
Action
Blue Ortho issued a DHCP notice to its active users on 08/30/2024 via email. The email informed users the software is being withdrawn from the US market until applicable pre-market approval is achieved. There are no actions users need to take. Blue Ortho requested users confirm receipt of the email.
Distribution
US Nationwide distribution.
Quantity
136 software units