Predict+ is a data-driven recall
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after…
Why was Predict+ is a data-driven recalled?
Predict+ is being recalled for lack of pre-market clearance/approval.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software version v1.3
- Product
- Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after…
- Recalling firm
- Blue Ortho
- Quantity
- 136 software units
- Distribution
- US Nationwide distribution.
- Recall date
- October 30, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)