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Use caution Medical device recall · FDA · Published July 28, 2017

Brainlab AIRO Mobile CT System Recall: Risk of Unintended Motion During Transport

Brainlab recalls AIRO Mobile CT System (MobiCT-32) due to risk of unintended motion in transport mode. All units released since April 2014 with specific serial numbers are affected.

🇺🇸 FDA recall #Z-0509-2018Medical deviceBrainlab ›
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Recalling firmBrainlab AGOlof-Palme-Strasse 9 · Munich, Germany
✎ GovInfoNow plain-language explainer

What happened, in plain English

Brainlab is recalling its AIRO Mobile CT System (model MobiCT-32) because it can move unexpectedly while in transport mode. This could cause injury if the device is not properly secured during movement. Read more at govinfonow.com/recall/73330-brainlab-airo-mobile-ct-system-recall-risk-of-unintended-motion.

Source Summary by GovInfoNow · govinfonow.com/recall/73330-brainlab-airo-mobile-ct-system-recall-risk-of-unintended-motion · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0509-2018

Cite this page

“Brainlab AIRO Mobile CT System Recall: Risk of Unintended Motion During Transport.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73330-brainlab-airo-mobile-ct-system-recall-risk-of-unintended-motion. Based on FDA recall #Z-0509-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0509-2018%22&limit=1).

Why it’s dangerous

The AIRO system can move unintentionally while in transport mode, which could lead to injury if the device is not securely fastened. This risk occurs when the system is being moved or transported without proper stabilization.

Who’s affected

Healthcare facilities using the AIRO Mobile CT System for X-ray imaging since April 2014 are affected. Patients and staff are at risk if the device moves unexpectedly during transport.

How to tell if you have this one

Check for serial numbers starting with AIRO- (e.g., AIRO-0106 to AIRO-0214). The device was released since April 2014 and is intended for adult patients weighing under 400 lbs (182 kg).

  • Brand
    Brainlab
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Verify your AIRO Mobile CT System's serial number to confirm if it is in the recall list (e.g., AIRO-0106 to AIRO-0214).

  2. Stop Using If Unsecured

    If the device moves unexpectedly during transport, stop using it immediately and secure it properly.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 27 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution - US Nationwide in the U.S. States: of AK, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, MT, MO, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, WA, and WV; and the countries of Argentina, Australia, Austria, Belgium,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, Arizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, West Virginia.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: Jul 28, 201712. FDA classified it Class II: Feb 2, 201823. Published in FDA’s Enforcement Report: Feb 14, 201834. FDA terminated the recall: Jul 25, 2018420172018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0509-2018 (July 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0509-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 20, 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