Blue Ortho is recalling approximately 136 units of its Predict+ clinical decision support software, version v1.3. Predict+ is a machine learning tool used by surgeons to predict patient outcomes after shoulder replacement surgery. This recall was initiated because the software was distributed without the required pre-market clearance or approval from the FDA, meaning its safety and effectiveness for clinical use have not been formally established.
The use of medical software that has not undergone FDA review poses a risk that surgical planning or patient outcome predictions could be inaccurate or unreliable, potentially leading to inappropriate clinical decisions. No injuries or incidents have been reported to date.
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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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