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Lumenis surgical devices slapped with FDA Class I recall

Tools

Israel's Lumenis faces a Class I FDA recall over certain models of the company's VersaCut Morcellator devices, which are used to break up and remove dissected tissue during surgery when there is limited access to the surgical site. The problem is pretty serious: A risk of air embolisms if the device's aspiration tubing is hooked up incorrectly, and Lumenis wants to correct the product's labeling and revise its operator's manual in order to correct the problem. According to the FDA, Lumenis has already placed an internal quarantine on the affected models it has in stock and sent affected customers an "urgent safety advisory notice" in early January, instructing customers on how to re-label the device. Recall notice