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 does not support the modification of the probe's image width.
Brainlab is recalling ultrasound navigation software versions 1.0 and 3.0.x/3.1.x because the software doesn't support changing the probe's image width. This could lead to inaccurate surgical guidance during minimally invasive procedures, potentially affecting precision and safety.
The software fails to allow adjustments to the probe's image width, which is critical for accurate real-time imaging during surgery. Without this feature, surgeons may not be able to properly visualize anatomical structures, increasing the chance of errors.
Surgical teams using Brainlab ultrasound navigation software for cranial or ENT procedures are likely affected. Patients undergoing minimally invasive surgery with these specific software versions are at risk of reduced precision.
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.
Review your software version to confirm if it matches the recalled versions (1.0 or 3.0.x/3.1.x).
The software does not support modifying the probe's image width, which could affect surgical precision during minimally invasive procedures.
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x.
Check your 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.
We’ve drafted a message you can send Brainlab to request your refund or repair — edit it as you like.
Subject: Recall Z-0056-2021 — Brainlab Brainlab Hello, I own a Brainlab that is covered by recall Z-0056-2021 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.
