Brainlab recalls Cirq Arm System 2.0 devices due to potential manufacturing errors causing mechanical instability. Affected units include all serial numbers and lot numbers.
Risk of mechanical instability due to potential manufacturing error of the device
Brainlab is recalling all Cirq Arm System 2.0 devices because of a potential manufacturing error that could cause mechanical instability. This means the device might not function safely, which could lead to injury.
The device may become unstable due to a manufacturing error, which could lead to injury if the device moves unexpectedly during use. This instability might not be noticeable until it causes harm.
Users of the Cirq Arm System 2.0 device are affected. Patients or medical staff using this device are most at risk due to potential mechanical instability.
Check the serial number or lot number on the device. All Cirq Arm System 2.0 units are affected, including those with the GTIN 04056481143961.
Verify the serial number or lot number to confirm if your device is affected.
The recall indicates a potential manufacturing error that could cause mechanical instability, so it is not safe to use without checking the recall status.
Check the serial number or lot number on the device; all Cirq Arm System 2.0 units are affected.
The recall does not specify a remedy, so contact Brainlab directly for further instructions.
We’ve drafted a message you can send Brainlab to request your refund or repair — edit it as you like.
Subject: Recall Z-1292-2023 — Brainlab Brainlab Hello, I own a Brainlab that is covered by recall Z-1292-2023 from Brainlab. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
