The Recall Desk
HighFDA (Devices)·Z-0176-2020·Announced 2019-10-30

Brainlab Patient Data Manager Software Recall for Data Export Errors

Brainlab is recalling Patient Data Manager software versions 2.1.1 through 2.5.1 because segmentation shifts may not be reflected in DICOM exports.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class II recall, and the defect involves a risk of harm (incorrect data export) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Brainlab AG is recalling the Patient Data Manager (PDM) software, specifically versions 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, and 2.5.1. This recall involves 1,230 units distributed worldwide. The software is intended to load and export patient data to connected network locations and removable media, and to start other Brainlab planning and navigation applications.

The recall is due to a defect where shifts applied to segmentation objects in the iPlan CMF/Cranial/ENT/Spine software may not be reflected when exported into DICOM under specific circumstances. This issue occurs when the Patient Data Manager is used in combination with iPlan CMF/Cranial/ENT/Spine software versions 3.0.5 or 3.0.6.

Healthcare facilities and users of this software should contact Brainlab AG for instructions on how to resolve the issue. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

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
Manufacturer
Brainlab AG
Category
Medical Device — Software
Hazard
Affected units
1,230

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • GTIN 04056481006662 2.3.1
  • GTIN 04056481132453 2.4.0
  • GTIN 04056481138615 2.5.0
  • GTIN 04056481140502 2.5.1
  • GTIN 04056481140502 versions 2.1.1
  • 2.2.0
  • 2.2.1
  • 2.3.0
  • 2.3.1
  • 2.4.0
  • 2.5.0
  • 2.5.1.

Distribution

Distribution scope not specified by the agency.

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