Cirq Arm System 2.0
Recall
- Recall Number
- Z-1292-2023
- Event Number
- 91781
- Firm
- Brainlab AG Olof-palme-str. 9 Munich Germany
- FEI Number
- 3002619595
- Product Code
- OLO
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 2, 2023
- Posted
- March 28, 2023
Description
Cirq Arm System 2.0
Risk of mechanical instability due to potential manufacturing error of the device
The firm issued a URGENT FIELD SAFETY NOTICE / PRODUCT NOTIFICATION to their consignees by email on 03/02/2023. The notice explained the issue, risk of use, and requested the following actions be taken: "1. Do not use Cirq Arm System 2.0 for clinical procedures. 2. Remove Cirq Arm System 2.0 from the OR table (as applicable), following the description given in the applicable User Guide. When lifting Cirq Arm System 2.0, ensure you carry the device only below joint 4 (see picture 1) to prevent user injury from falling parts. 3. Store the device in the corresponding transport and storage case delivered with it and ensure you mark the equipment appropriately to prevent it from being used inadvertently." Brainlab is seeking return of the devices for inspection and repair (if applicable).
Texas
1 unit