+ HEALTH Aims Intramuscular fat (IMF) is increasingly recognized as a marker of ectopic adiposity and adverse cardiome…+ HEALTH Periapical lesions are challenging to detect on intraoral radiographs because of anatomical superimposition a…± HEALTH Ultrasound imaging is an indispensable diagnostic tool, yet its profound reliance on operator expertise inher…+ HEALTH Objectives We adapted the individualized polysocial risk score (iPsRS), a machine learning model originally d…± HEALTH Melioidosis is a life-threatening infectious disease caused by Burkholderia pseudomallei ( Bp ). Rapid diagno…+ HEALTH Classification is a core machine learning task, and ensemble voting methods are widely used to improve predic…+ CLIMATE Microplastic (MP) pollution poses escalating environmental risks, demanding efficient and reproducible tools…± HEALTH Medicinal chemistry sits at the center of modern drug discovery, yet translating molecular designs into appro…
TruaceTracing the truth around AIWednesday, August 26, 2026
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TRV-2026-0044Version 2 · Sources changed

Written 2026-07-12 20:50:54 UTC · current record

Reason for this version

Source set updated

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TRUVACE RECORD VERSION
record: TRV-2026-0044
version: 2
kind: sources_changed
reason: Source set updated
timestamp: 2026-07-12T20:50:54.832822Z
status: published
lens: p_space
sector: health
headline: Blue Ortho 22 Chemin Du Vieux Chene Meylan France recalls an AI-enabled medical device
dek: 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.
gain_reading: (none)
problem_reading: FDA recall data identifies an AI-enabled medical device removed or corrected because predict+ is being recalled for lack of pre-market clearance/approval.
limitation: A recall record documents a correction or removal; it does not establish the failure rate of every device using similar AI methods.
tag: Evidence-backed problem
key_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 The email informed users the software is being withdrawn from the US market until applicable pre-market approval is achieved.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…
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:
- peer_reviewed | npj Digital Medicine | https://doi.org/10.1038/s41746-026-02353-7 | 2026-02-05
- government | FDA medical-device recall 209984 | https://api.fda.gov/device/recall.json?search=cfres_id%3A%22209984%22&sort=event_date_created%3Adesc&limit=1 | 2024-08-30
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