Reported Aug 6, 2014 · Terminated
Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A…
Brainlab AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brainlab AG · Kapellenstrasse 12 · Feldkirchen · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Model/Catalog Numbers25100-05 PATIENT DATA MANAGER 2.0.11 25100-06 PATIENT DATA MANAGER 2.0.2
- Software Versions
2.0.02.0.1and 2.0.2
- Amount recalled
- 154 systems
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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