Recall
Cirq Arm System 2.0
Brainlab AG · 2 March 2023
- Status
- Recall open, classified
- Why, in the FDA's words
- “Risk of mechanical instability due to potential manufacturing error of the device”
- Recall began
- 2 March 2023
- Company
- Brainlab AG
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K222966
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.