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Use caution Medical device recall · FDA · Published March 2, 2023

Brainlab Cirq Arm System 2.0 Recall: Risk of Mechanical Instability

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.

🇺🇸 FDA recall #Z-1292-2023Medical deviceBrainlab ›
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Recalling firmBrainlab AGOlof-palme-str. 9 · Munich, Germany
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/58796-brainlab-cirq-arm-system-2-0-recall-risk-of-mechanical.

Source Summary by GovInfoNow · govinfonow.com/recall/58796-brainlab-cirq-arm-system-2-0-recall-risk-of-mechanical · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1292-2023

Cite this page

“Brainlab Cirq Arm System 2.0 Recall: Risk of Mechanical Instability.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/58796-brainlab-cirq-arm-system-2-0-recall-risk-of-mechanical. Based on FDA recall #Z-1292-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1292-2023%22&limit=1).

The FDA announced on March 2, 2023, that Brainlab AG is voluntarily recalling the Cirq Arm System 2.0 due to a risk of mechanical instability from potential manufacturing errors. Owners should contact the company for remedy details.

How to tell if you have it

  • Brand: Brainlab
  • Product: Cirq Arm System 2.0
  • UPC: 04056481143961
  • Distribution: Texas

The hazard

The device poses a risk of mechanical instability due to a potential manufacturing error, according to the FDA. The recall covers all available serial numbers and lot numbers for the Cirq Arm System 2.0.

Context

GovInfoNow's records show Brainlab AG has had 15 other recalls since July 28, 2017. Recent brand recalls include the Feb. 10, 2025, Brainlab Origin Data Management Software recall for merged patient records and the Feb. 14, 2023, Brainlab ExacTrac Software recall for potential DIBH functionality issues. Other recent recalls of similar products include the Jan. 26, 2026, Philips Azurion 7 B20 System recall and the May 22, 2026, Hamilton Medical IntelliCuff recall.

How to tell if you have this one

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.

  • Brand
    Brainlab
  • Product
    Cirq Arm System 2.0
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Status

    Verify the serial number or lot number to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed in Texas.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “Texas” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Texas.

Recall timeline

FDA published this recall 34 days after the firm started it.

1. Firm started the recall: Mar 2, 202312. FDA classified it Class II: Mar 28, 202323. Published in FDA’s Enforcement Report: Apr 5, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1292-2023 (March 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1292-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA