Spine SrsRecalls & reported problems across all models

We found 2 models of Spine Srs 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

Spine Srs 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. Mar 11, 2019Terminated

   There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting.

   Z-1205-2019 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Spine Srs models

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

• Spine Srs 1.0

  System,Planning,Radiation Therapy Treatment
  1 recall0 reports
• Spine Srs 1.5

  System,Planning,Radiation Therapy Treatment
  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
• Origin Data Management / Patient Data Manager2 models · 0 reports · 1 recall