Lower risk Medical device recall · FDA · Published September 25, 2019

Brainlab Patient Data Manager Software Recall: Data Sync Errors with iPlan

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0176-2020Medical device Brainlab ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmBrainlab AGOlof-palme-str. 9 · Munich, Germany

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/66963-brainlab-patient-data-manager-software-recall-data-sync-errors-with.

Source Summary by GovInfoNow · govinfonow.com/recall/66963-brainlab-patient-data-manager-software-recall-data-sync-errors-with · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0176-2020

Cite this page

“Brainlab Patient Data Manager Software Recall: Data Sync Errors with iPlan.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66963-brainlab-patient-data-manager-software-recall-data-sync-errors-with. Based on FDA recall #Z-0176-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0176-2020%22&limit=1).

The FDA announced on 2019-09-25 that Brainlab AG voluntarily recalled Patient Data Manager software due to a hazard where segmentation shifts may not be reflected upon export. The agency issued recall number Z-0176-2020 for the Class II device.

How to tell if you have it

Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY
Patient Data Manager, Model/Catalogue Numbers: 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY
Patient Data Manager, Model/Catalogue Numbers: 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY
Patient Data Manager, Model/Catalogue Numbers: 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER
Patient Data Manager, Model/Catalogue Numbers: 25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER
Patient Data Manager, Model/Catalogue Numbers: 25100-13 - PATIENT DATA MANAGER 2.3 LICENSE
Patient Data Manager, Model/Catalogue Numbers: 25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER
Patient Data Manager, Model/Catalogue Numbers: 25100-13A - PATIENT DATA MANAGER 2.4 LICENSE
Patient Data Manager, Model/Catalogue Numbers: 25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER
Patient Data Manager, Model/Catalogue Numbers: 25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER
Patient Data Manager, Model/Catalogue Numbers: 25100-13B - PATIENT DATA MANAGER 2.5 LICENSE

The hazard

GovInfoNow's records show the hazard involves Patient Data Manager software in combination with specific iPlan CMF/Cranial/ENT/Spine software versions, where shifts applied to segmentation objects may not be reflected when exported into DICOM under specific circumstances.

Context

Brainlab AG has 15 other recalls on record since 2017-07-28. Other recent recalls of similar products include Brainlab Origin Data Management Software Recalled: Patient Records Merged Without Notice (2025-02-10), Brainlab Cirq Arm System 2.0 Recall: Risk of Mechanical Instability (2023-03-02), and Brainlab ExacTrac Software Recall: DIBH Functionality May Not Work Correctly (2023-02-14). Other recent recalls of similar products include Intelerad InteleShare Software Recall: Inaccurate Measurements Risk Misdiagnosis (2025-11-18) and Nova Biomedical StatStrip Glucose Meter System Recall: Patient Data Mismatch Risk (2026-07-29).

How to tell if you have this one

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.

Brand
Brainlab
Product
Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Versions
Verify your Patient Data Manager version matches the listed numbers (2.1.1 through 2.5.1) and iPlan software versions.

How this recall unfolded

Recall timeline

FDA terminated this recall 4.5 years after the firm started it.

Sep 25, 2019Firm started the recall
Oct 23, 2019FDA classified it Class II
Oct 30, 2019Published in FDA’s Enforcement Report
Mar 25, 2024FDA terminated the recall

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

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Keep exploring

More Brainlab recalls

Link to this recall

<a href="https://govinfonow.com/recall/66963-brainlab-patient-data-manager-software-recall-data-sync-errors-with">Brainlab Patient Data Manager Software Recall: Data Sync Errors with iPlan (GovInfoNow)</a>

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-0176-2020 (September 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0176-2020 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.