Cirq Arm System 2.0 recallZ-1292-2023 · Brainlab AG · initiated Mar 2, 2023
Class II Open, Classified All recalls posted in March 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Brainlab AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Risk of mechanical instability due to potential manufacturing error of the device
FDA root cause category: Nonconforming Material/Component
What the company is doing
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).
Recall details
- Recall number
- Z-1292-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Mar 2, 2023
- Posted by the FDA
- Mar 28, 2023
- Recalling firm
- Brainlab AG
- Quantity
- 1 unit
- Product code
- OLO
- FDA submissions
- K222966
- Distribution
- Texas
Product description
Cirq Arm System 2.0
Code information (models, lots, serial numbers)
56500 CIRQ ARM SYSTEM 2.0; GTIN 04056481143961; All available Serial numbers/lot numbers are affected.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cirq Arm System 2.0 56500Brainlab SE · Neurological Stereotaxic Instrument1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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