Origin Data Management / Patient Data ManagerRecalls & reported problems across all models

We found 2 models of Origin Data Management / Patient Data Manager by Brainlab SE in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Origin Data Management / Patient Data Manager recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 25, 2019Terminated

   The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6) that may lead to shifts applied to segmentation objects in iPlan being not reflected when exported into DICOM under specific circumstances.

   Z-0176-2020 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

Origin Data Management / Patient Data Manager models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Origin Data Management / Patient Data Manager 2.3

  Digitizer, Image, Radiological
  1 recall0 reports
• Origin Data Management / Patient Data Manager 2.3.1

  Digitizer, Image, Radiological
  1 recall0 reports

Other Brainlab SE products

• Spine & Trauma 3D Navigation2 models · 131 reports · 1 recall
• Spine & Trauma Navigation2 models · 139 reports
• Navigation Software Spine & Trauma 3D2 models · 108 reports
• Cranial2 models · 64 reports
• Exactrac2 models · 6 reports · 1 recall
• ExacTrac Dynamic2 models · 2 reports · 1 recall
• Spine Srs2 models · 0 reports · 1 recall