− CLIMATE — Artificial intelligence is often associated with ludicrous amounts of electricity, and therefore planet-heati…+ EDUCATION — While many schools in England have banned smartphones, in Estonia – regarded as the new European education po…− EDUCATION — In a Cambridge classroom, Joseph, 10, trained his AI model to discern between drawings of apples and drawings…− EDUCATION — OpenAI CEO Sam Altman recently told a US podcast that if he was graduating today, “I would feel like the luck…− EDUCATION — I disagree with the decision of lecturers to use artificial intelligence to create teaching materials (‘We co…− BUSINESS — Americans are growing worried about what artificial intelligence portends for their futures. Eight in 10 Amer…− BUSINESS — Accenture has reportedly begun calling its near 800,000 employees “reinventors”, as the consultancy tries to…− LABOR — US workers overwhelmingly support pro-worker policies on artificial intelligence (AI) and view labor unions a…
TruaceTracing the truth around AISunday, July 12, 2026
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TRV-2026-0044Version 1 · Certified

Written 2026-07-12 20:50:17 UTC · current record

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TRUVACE RECORD VERSION
record: TRV-2026-0044
version: 1
kind: certified
reason: Certified into the record
timestamp: 2026-07-12T20:50:17.916097Z
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 The email informed users the software is being withdrawn from the US market until applicable pre-market approval is achieved.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:
- 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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