Surgical Brain Guidance System Recalled for Inaccurate Electrode Placement
ROSA One 3.1 surgical guidance system recalled due to a software anomaly causing inaccurate electrode placement during brain and spine surgery. Manufacturer received 3 complaints related to the issue.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, which qualifies for Critical severity according to the rubric. A software defect causing inaccurate electrode placement during brain surgery presents a direct risk of serious injury or death.
Plain-English summary
MEDTECH SAS is recalling 119 units of the ROSA One 3.1 Brain application distributed in the United States and 55 units distributed internationally to Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands. The device is a surgical guidance system used to help position and orient instrument holders during brain and spine surgeries.
A software anomaly affecting the application has resulted in inaccurate electrode placement during surgical procedures. The manufacturer has received three complaints related to this issue.
An incorrect electrode trajectory could result in serious injury or death if not detected during surgery. Healthcare facilities with affected serial numbers should consult FDA recall notice Z-0118-2022 for detailed information and guidance on next steps.
The recalled product
- Product
- ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
- Manufacturer
- MEDTECH SAS
Distribution
Distributed nationwide across the United States.
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Similar recalls
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