TRV-2026-0042Version 1 · Certified
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TRUVACE RECORD VERSION record: TRV-2026-0042 version: 1 kind: certified reason: Certified into the record timestamp: 2026-07-12T20:50:17.774948Z status: published lens: p_space sector: health headline: Ossur H F Grjothals 5 Reykjavik Iceland recalls an AI-enabled medical device dek: 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. gain_reading: (none) problem_reading: 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. 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: Ossur H F Grjothals 5 Reykjavik Iceland. | FDA’s stated 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. | Corrective action: The firm, Ossur, notified their customers of the Recall Notice via phone on February 26, 2015. The firm informed the customers about the recalled product, the problem and actions to be taken. The customers were instruct… rundown: 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 to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed. 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. The firm, Ossur, notified their customers of the Recall Notice via phone on February 26, 2015. The firm informed the customers about the recalled product, the problem and actions to be taken. The customers were instructed to send the unit in for service so the Acceptance testing can be performed fo… sources: - government | FDA medical-device recall 134496 | https://api.fda.gov/device/recall.json?search=cfres_id%3A%22134496%22&sort=event_date_created%3Adesc&limit=1 | 2015-02-26 prev: 0000000000000000000000000000000000000000000000000000000000000000
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