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Zimmer Surgical Robot Class I Recall Due To Software Glitch

 
• By Elizabeth Orr

The problem could cause incorrect display of neurological scans that could potentially lead to errors in surgical planning.

Zimmer ROSA One surgical robot in use.
• Source: Zimmer Biomet

Zimmer Biomet Holdings, Inc. is recalling its ROSA One 3.1 Brain Application, a robotic platform designed to help neurosurgeons position medical tools during surgery. The US Food and Drug Administration, which announced the recall on 29 October, has identified the action as a high-risk class I recall.

The ROSA One has a robotic arm to which instruments can be connected and a touch screen mounted on a...

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More from Policy & Regulation

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• By Elizabeth Orr

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Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 
• By Brian Bossetta

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