According to an online news report on HealthImaging.com, the FDA announced a Class I recall concerning Zimmer Biomet’s ROSA One 3.1 Brain application. The FDA notice warns healthcare providers and patients about a software issue that may cause the robotic arm to shut down unexpectedly. Zimmer Biomet’s robotic platform is used to help neurosurgeons position medical instruments during brain surgery.
Zimmer Biomet initiated the recall of the device due to a software error that may cause the incorrect placement of surgical instruments during stereotactic neurosurgical procedures. The device directs the tip of a surgical tool using coordinates given by medical imaging to enter a precise part of the brain. Incorrect placement of a brain surgery tool can cause adverse medical events such as serious injury, stroke, severe disability, and death.
The medical device is comprised of a compact robotic arm, a touch screen, and various surgical tools such as biopsy needles, endoscopes, and stimulation or recording electrodes. These tools can be attached to the tip of the robotic arm.
The Zimmer Biomet recall states the software defect can cause the platform to shut down. After the platform is rebooted, the programmed trajectory can be disrupted, leading the device to operate on an incorrect track. The device could cause adverse incidents, including stroke, severe disability, serious injury, and death when this happens.
For specific information regarding the recall, you can view the FDA’s announcement here.
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