Brainlab recalls Patient Data Manager software versions 2.1.1-2.5.1 used with iPlan CMF/Cranial/ENT/Spine 3.0.5-3.0.6 due to potential segmentation errors when exporting to DICOM.
The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6) that may lead to shifts applied to segmentation objects in iPlan being not reflected when exported into DICOM under specific circumstances.
Brainlab is recalling specific versions of its Patient Data Manager software that may cause segmentation data to not sync properly when exported to DICOM files. This could lead to inaccurate medical imaging data being used in patient treatment.
The software may not correctly reflect segmentation objects when exporting medical imaging data to DICOM files under specific conditions. This could cause inaccurate measurements in patient treatment planning, but does not directly harm patients.
Medical professionals using Brainlab Patient Data Manager software with compatible iPlan versions. The risk is low as the issue only affects data export accuracy, not patient safety.
Check if you have Patient Data Manager software versions 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, or 2.5.0/2.5.1 used with iPlan CMF/Cranial/ENT/Spine 3.0.5 or 3.0.6.
Verify your Patient Data Manager version matches the listed numbers (2.1.1 through 2.5.1) and iPlan software versions.
No, the recall does not require immediate discontinuation. The issue is low risk and only affects data export accuracy.
The recall does not specify a remedy, so no action is required beyond checking your software versions.
The issue could cause inaccurate segmentation data in exported DICOM files, but it does not directly impact patient safety.
We’ve drafted a message you can send Brainlab to request your refund or repair — edit it as you like.
Subject: Recall Z-0176-2020 — Brainlab Brainlab Hello, I own a Brainlab that is covered by recall Z-0176-2020 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.
