FDASeptember 21, 2015device
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage med...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.
What to do
FDA enforcement status: Terminated
Brands named
brainlab agbrainlab
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOrigin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.12025-02-10
- FDACirq Arm System 2.02023-03-02
- FDABrainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.2023-02-14
- FDAExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.2022-02-25
- FDAExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patie...2021-05-14
- FDAExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).2021-03-01
- FDAUltrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.2020-08-31
- FDACirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)2020-08-20
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