Brainlab recalls ultrasound navigation software versions 1.0 and 3.0.x/3.1.x due to inability to modify probe image width. This may affect surgical precision during minimally invasive procedures. Affected units include specific model numbers and subscription packages.
“Brainlab Ultrasound Navigation Software Recall: Image Width Modification Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64388-brainlab-ultrasound-navigation-software-recall-image-width-modification-issue. Based on FDA recall #Z-0056-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0056-2021%22&limit=1).
Brainlab AG recalled Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x due to a hazard where the software does not support modification of the probe's image width, according to the FDA. The agency announced the recall on Aug. 31, 2020.
How to tell if you have it
Ultrasound Navigation Software 1.0
Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x
Model/catalogue numbers: 22582 IGSONIC BK MEDICAL SOFTWARE, 22582A ULTRASOUND INTEGRATION SW (BK), 22582B ULTRASOUND INTEGRATION SW, 22583 LICENSE UPDATE TO IGSONIC SW FOR BK MED, 26506 ULTRASOUND SW BK800 SUBSCRIPTION, 26506A ULTRASOUND SW BK SUBSCRIPTION, 26508A ULTRASOUND SW BK UPDATE
GTIN for Ultrasound Navigation 1.0: 04056481140137
GTIN for Cranial/ENT Navigation 3.1: 04056481132439
The hazard
The recalled Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width, according to the FDA.
Context
GovInfoNow's records show Brainlab AG has 15 other recalls on record since 2017-07-28. Other recent recalls include Brainlab Origin Data Management Software Recall (2025-02-10), Brainlab Cirq Arm System 2.0 Recall (2023-03-02), and Brainlab ExacTrac Software Recall (2023-02-14). Other recent recalls of similar products include PIE Medical Imaging 3mensio Workstation Software Recall (2026-05-07), Philips EPIQ Elite Ultrasound System Recall (2026-08-07), and GE Medical Systems Imactis CT-Navigation System Recall (2026-02-03).
How to tell if you have this one
Check for model numbers: 22582 IGSONIC BK MEDICAL SOFTWARE, 22582A ULTRASOUND INTEGRATION SW (BK), 22582B ULTRASOUND INTEGRATION SW, 22583 LICENSE UPDATE, 26506 ULTRASOUND SW BK800 SUBSCRIPTION, 26506A ULTRASOUND SW BK SUBSCRIPTION, or 26508A ULTRASOUND SW BK UPDATE. These software versions were sold with specific GTINs.
Brand
Brainlab
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Review your software version to confirm if it matches the recalled versions (1.0 or 3.0.x/3.1.x).
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of Illinois, Massachusetts, Texas, California, Idaho, Missouri, Oregon, Connecticut and the countries of Australia, Austria, Belgium, Brazil, Canada, China,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Connecticut, Idaho, Illinois, Massachusetts, Missouri, Oregon, Texas.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0056-2021 (August 31, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0056-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.