The Recall Desk

FDA (Devices) recall action 72804

Brainlab AG recalled 2 products on 2016-01-20

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-01-20
Critical
0
Units
68

Why these products were recalled

Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.

Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2016-01-20

    Brainlab Brain Metastases Software Recall for Image Display Errors

    Brainlab AG is recalling Brain Metastases 1.0.0 software because large objects may display cropped during import.

    Product
    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor bo
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-01-20

    Brainlab RT Elements software recall for image cropping defect

    Brainlab AG is recalling RT Elements software because large objects may display cropped during import, potentially affecting radiation treatment planning.

    Product
    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor bo
    Category
    Distribution
    0 states