FDA recall Z-1292-2023
Brainlab AG · Class II · device
Product
Cirq Arm System 2.0
Reason for recall
Risk of mechanical instability due to potential manufacturing error of the device
Distribution
Texas
Key facts
- Status
- Ongoing
- Initiation date
- 2023-03-02
- Report date
- 2023-04-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Munich, N/A, Germany
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1292-2023