FDA Identifies Robotic Surgery Software Recall as Class I

Samara Rosenfeld
NOVEMBER 08, 2019
robot
Photo/Thumb have been modified. Courtesy of jayfish - stock.adobe.com.

Just over a year after the U.S. Food and Drug Administration (FDA) granted premarket clearance to Zimmer Biomet’s robotic surgery system, the software, Rosa Brain 3.0, was recalled due to issues that incorrectly positioned the robotic arm.

Zimmer Biomet, a medical device manufacturer, received five complaints due to the software issue, which could result in risks for the patient. One patient reported injury, while at this point, no deaths have been reported.

Due to the seriousness of the issue, the FDA identified the recall as Class I — the most serious of its type.

A list released by the FDA contained 93 product codes that were affected.

Inside Digital Health™ made several attempts to learn more about the software recall but could not get a hold of any Zimmer Biomet representatives.

Rosa Brain 3.0 is a robotic platform that assists neurosurgeons in positioning medical instruments or implants during surgery. The software serves a similar purpose to its Rosa platform for knee replacement surgery.

Zimmer Biomet issued an Urgent Medical Device Correction to product customers in Sept. 2019 to tell them recommendations and next steps. As part of the plan, Zimmer Biomet sent an engineer to each customer to implement an updated software.  

Among those affected included neurosurgeons, assisting medical personnel and patients who received neurosurgery with the aid of a Rosa Brain 3.0 device.

This is not the first time Rosa Brain 3.0 has been recalled by the FDA.

In 2017, the agency issued a Class II device recall due to an unapproved change made by the supplier.

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