Cirq Arm System 2.0
FDA device recall Z-1292-2023 · posted 2023-03-28 · Open, Classified
Recall details
- Recalling firm
- Brainlab AG
- Reason for recall
- Risk of mechanical instability due to potential manufacturing error of the device
- Action taken
- 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).
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- OLO
- Quantity affected
- 1 unit
- Distribution
- Texas
- Date initiated
- 2023-03-02
- Date posted
- 2023-03-28
- Location
- Munich, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cirq Arm System (2.0);Alignment System Spine (K222966) | Brainlab AG | 2022-10-27 |