Recall Z-2134-2014— Brainlab AG

Name: FDA recall Z-2134-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-27

Class II · Terminated

Class II FDA medical device recall by Brainlab AG, initiated 2014-06-27, terminated 2017-04-24. It names one FDA 510(k) clearance: K093117. 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.. 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.

Recalling firm: Brainlab AG
Classification: Class II
Status: Terminated
Initiated: 2014-06-27
Terminated: 2017-04-24
Firm location: Feldkirchen, Germany

510(k) clearances named in this recall

1 on FDA's record

K093117 — DIGITAL LIGHTBOXBrainlab AG·cleared 2009-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.