11
Jun
2014

Cl II Brainlab Patient Data Manager 2.0

,
0

Company: BRainlab AG.
Date of Enforcement Report:6/11/2014
Class lI:

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 communication systems (PACS), file servers, or removable storage media.
Recall Number Z-2134-2014

REASON
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 be displayed. For non-square pixels, the pixel width x is different to the pixel height y. Due to a software error in PDM 2.0, the x and y values are swapped, leading to the result that each individual pixel appears rotated by 90 degrees. This results in a distorted display of the image data. The magnitude of distortion may vary, depending on the Pixel Aspect Ratio, the ratio of width and height of a pixel. Accordingly, for some cases the data distortion will be clearly visible on the Brainlab planning or navigation system, e.g. during the review of the data or when performing the initial patient registration. However, if a non-obvious distortion would occur and not be detected during review of the data, the deviation of the information displayed in the planning or navigation software could mislead the user regarding clinical decisions. 2) It has been determined that non-square pixel data is not suitable for dose calculation with the current Brainlab iPlan RT systems. The actual delivered treatment dose might be different from the dose shown in the treatment plan.

RECALLING FIRM/MANUFACTURER
Brainlab AG , Feldkirchen, DE on 6/27/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
154 systems

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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