aceBlue 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.
Predict+ was recalled because the AI-enabled clinical decision support tool for shoulder replacement outcomes lacked required pre-market clearance/approval.
Article text provides only recall reason and device purpose; no details on patient harm, distribution volume, or regulatory action timeline.
Evidence
- Peer-reviewednpj Digital Medicine2026-02-05
- GovernmentFDA medical-device recall 2099842024-08-30
How should this claim be treated?
Truvace Impact Record TRV-2026-0044, v4: “Blue Ortho 22 Chemin Du Vieux Chene Meylan France recalls an AI-enabled medical device.” Truvace, 2026-07-13. /record/TRV-2026-0044 (accessed at citation time). sha256 ad307d730f38f654…
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