Ossur 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.
FDA recall data identifies an AI-enabled medical device removed or corrected because 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.
A recall record documents a correction or removal; it does not establish the failure rate of every device using similar AI methods.
Evidence
- GovernmentFDA medical-device recall 1344962015-02-26
Truvace Impact Record TRV-2026-0042, v1: “Ossur H F Grjothals 5 Reykjavik Iceland recalls an AI-enabled medical device.” Truvace, 2026-07-12. /record/TRV-2026-0042 (accessed at citation time). sha256 ecd23fe13d3d7ad5…
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