aceOssur H F Grjothals 5 Reykjavik Iceland recalls an AI-enabled medical device
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately t… Recall reason: The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.
Lower-extremity amputees received Rheo Knee AI prosthetics that had been released without completing the full assembly process, triggering a recall for acceptance testing
Evidence
- GovernmentFDA medical-device recall 1344962015-02-26
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Truvace Impact Record TRV-2026-0042, v2: “Ossur H F Grjothals 5 Reykjavik Iceland recalls an AI-enabled medical device.” Truvace, 2026-07-13. /record/TRV-2026-0042 (accessed at citation time). sha256 aef169155dd630d2…
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