Recall Z-1292-2023 ยท OLO Orthopedic Stereotaxic Instrument
Brainlab AG
Cirq Arm System 2.0
| Date | Mar 28, 2023 (initiated Mar 2, 2023) |
| Status | Open, Classified |
| Reason | Risk of mechanical instability due to potential manufacturing error of the device |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 1 unit |
| Distribution | Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222966 | Cirq Arm System (2.0);Alignment System Spine Brainlab AG, Oct 27, 2022 |