Device product
Cirq Arm System 2.0
Z-1292-2023
Product summary
- Firm
- Brainlab AG
- Event
- Event 91781
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1292-2023
Official wording
Reason: Risk of mechanical instability due to potential manufacturing error of the device
Code information: 56500 CIRQ ARM SYSTEM 2.0; GTIN 04056481143961; All available Serial numbers/lot numbers are affected.
Distribution pattern: Texas
Derived failure modes
-
Manufacturing or process control
manufacturing error