CLASS II Device recall · Reported 6 Aug 2014 · FDA Enforcement Report

Patient Data Manager 0 (Content manager recalled by Brainlab AG

Brainlab AG is recalling Patient Data Manager 0 (Content manager 0, Patient Browser 0, Dicom Viewer 0) Brainlab, distributed nationwide in the US. The recall was initiated on 27 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Numbers: 25100-05 PATIENT DATA MANAGER 2.0.11 25100-06 PATIENT DATA MANAGER 2.0.2. Software Versions: 2.0.0, 2.0.1, and 2.0.2

Quantity recalled154 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2134-2014
FDA event ID: 68737
Recalling firm: Brainlab AG, Feldkirchen
Classification: Class II
Status: Terminated
Recall initiated: 27 Jun 2014
FDA classified: 30 Jul 2014
Reported: 6 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

27 Jun 2014	Recall initiated by company
30 Jul 2014	Classified by FDA	+33 days
6 Aug 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When loading non-square pixel image data with PDM 2.0, the data set is not correctly transferred and displayed in the corresponding Brainlab navigation or planning software. When a data set is loaded, the pixels of the data set are sorted in order to

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 communication systems (PACS), file servers, or removable storage media.

Where it was distributed

Worldwide Distribution-USA (nationwide) including the states of AL, AK, AZ, CA, FL, GA, IA, IL, KS, MD, MO, MS, NC, NY, OH, PA, SD, TX, VA, VT, WA, and WI, and the countries of Australia, Austria, Belgium, Brazil, Chile, China, Ecuador, France, Germany, Japan, Netherlands, New Zealand, Norway, Qatar, Russia, Spain, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.

Nationwide Alaska Alabama Arizona California Florida Georgia Iowa Illinois Kansas Maryland Missouri Mississippi North Carolina New York Ohio Pennsylvania South Dakota Texas Virginia Vermont

Questions about this recall

Is Patient Data Manager 0 (Content manager 0, Patient Browser 0, Dicom Viewer 0) Brainlab recalled?

Yes. Brainlab AG recalled Patient Data Manager 0 (Content manager 0, Patient Browser 0, Dicom Viewer 0) Brainlab on 27 Jun 2014. The recall is Class II and its status is Terminated. Recall number Z-2134-2014.

Why was it recalled?

Which lots are affected?

Model/Catalog Numbers: 25100-05 PATIENT DATA MANAGER 2.0.11 25100-06 PATIENT DATA MANAGER 2.0.2. Software Versions: 2.0.0, 2.0.1, and 2.0.2

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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