PATIENT DATA MANAGER 2.4 INSTALLERRecalls & reported problems
Brainlab SE · Class 2
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- 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 · FDA record ↗
Other Digitizer, Image, Radiological devices
- Patient Data Manager 2.5Brainlab SE · Digitizer, Image, Radiological1 recall0 reports
- Origin Data Management / Patient Data Manager 2.3Brainlab SE · Digitizer, Image, Radiological1 recall0 reports
- Origin Data Management / Patient Data Manager 2.3.1Brainlab SE · Digitizer, Image, Radiological1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.