Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2134-2014 — 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), fi

U.S. FDA — Device Enforcement · Germany · 2014-06-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2134-2014
Date of alert: 2014-06-27
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: Brainlab AG
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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