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Health·P Space·Evidence-backed problem·Published 2026-07-12

Blue Ortho 22 Chemin Du Vieux Chene Meylan France recalls an AI-enabled medical device

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 reason: Predict+ is being recalled for lack of pre-market clearance/approval.

TRV-2026-0044Peer-reviewed ×2Permanent record — cite & verify
Blue Ortho 22 Chemin Du Vieux Chene Meylan France recalls an AI-enabled medical device

"Sarasota - Janet in Doctors Hospital" by roger4336 is licensed under CC BY-SA 2.0. To view a copy of this license, visit https://creativecommons.org/licenses/by-sa/2.0/.

Main points
  • Recalling firm: Blue Ortho 22 Chemin Du Vieux Chene Meylan France.
  • FDA’s stated reason: Predict+ is being recalled for lack of pre-market clearance/approval.
  • Corrective 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 The email informed users the software is being withdrawn from the US market until applicable pre-market approval is achieved.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 act…
Problem

FDA recall data identifies an AI-enabled medical device removed or corrected because predict+ is being recalled for lack of pre-market clearance/approval.

The rundown

Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery

Predict+ is being recalled for lack of pre-market clearance/approval. 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 The email informed users the software is being withdrawn from the US market until applicable pre-market approval is achieved.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.

Sources

The debate