# FDA recall Z-0176-2020

> **Brainlab AG** · Class II · device recall initiated 2019-09-25.

## Product

Patient Data Manager, Model/Catalogue Numbers:    25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY  25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY  25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY   25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER    25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER   25100-13 - PATIENT DATA MANAGER 2.3 LICENSE    25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER   25100-13A - PATIENT DATA MANAGER 2.4 LICENSE    25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER   25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER   25100-13B - PATIENT DATA MANAGER 2.5 LICENSE  used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6. Product Usage: Patient Data Manager is intended to load patient data from and export patient data to connected network locations (like file shares and PACS) and removable media. Furthermore, the software is intended to start other applications (like Brainlab planning and navigation applications) and to route applications and connec

## Reason for 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.

## Distribution

worldwide

## Key facts

- **Recall number:** Z-0176-2020
- **Recalling firm:** Brainlab AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-25
- **Report date:** 2019-10-30
- **Termination date:** 2024-03-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0176-2020

## Citation

> AI Analytics. FDA recall Z-0176-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0176-2020. Source: US FDA. Licensed CC0.

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