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TruaceTracing the truth around AISunday, July 12, 2026
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TRV-2026-0044Certified recordPeer-reviewed ×2

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.

Health · P Space — documented harm · certified 2026-07-12 · v2 · article view · machine-readable

Current reading — 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.

What this doesn’t fix

A recall record documents a correction or removal; it does not establish the failure rate of every device using similar AI methods.

Evidence

Cite this record

Truvace Impact Record TRV-2026-0044, v2: “Blue Ortho 22 Chemin Du Vieux Chene Meylan France recalls an AI-enabled medical device.” Truvace, 2026-07-12. /record/TRV-2026-0044 (accessed at citation time). sha256 ccb862a9480e34b5…

Calibration history

Every change to this record since certification, in the open.

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    Source set updated

  2. Certifiedv1982d46cfba51…

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