Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2134-2014·Announced 2014-08-06

Brainlab Patient Data Manager 2.0 Software Recall for Image Display Defects

Brainlab AG is recalling Patient Data Manager 2.0 software due to defects in transferring and displaying non-square pixel medical images.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The defect involves incorrect data transfer and display of medical images, which is a functional error rather than a direct physical hazard like a fire or choking risk, and no injuries or illnesses are reported in the source text.

Plain-English summary

Brainlab AG is recalling 154 units of the Patient Data Manager 2.0 software system, including models 25100-05 and 25100-06. The affected software versions are 2.0.0, 2.0.1, and 2.0.2. This system is used for the display of medical images and can transfer data to and from picture archiving and communication systems (PACS), file servers, or removable storage media.

The recall is due to identified defects in how the software handles data loaded with Patient Data Manager version 2.0. Specifically, when loading non-square pixel image data, the data set is not correctly transferred and displayed in the corresponding Brainlab navigation or planning software. The source text notes that pixels are sorted in a manner that leads to this incorrect transfer and display.

The affected systems were distributed worldwide, including nationwide in the United States and in various countries such as Australia, Austria, Belgium, Brazil, Chile, China, Ecuador, France, Germany, Japan, Netherlands, New Zealand, Norway, Qatar, Russia, Spain, Switzerland, Taiwan, United Arab Emirates, and the United Kingdom. Users of this software should contact Brainlab AG for further instructions regarding the recall and potential software updates or replacements.

The recalled product

Product: Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and…
Manufacturer: Brainlab AG
Category: Medical Device — Medical Imaging Software
Hazard: software-defect
data-integrity
Affected units: 154

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 (2)

2.0.1
and 2.0.2

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Same manufacturer · Brainlab AG

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