Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2019-03-11 | Z-1205-2019 | Class II | Terminated | 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.Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KY, LA, MA, MD, MS, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, & WV. Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, El Salvador, Finland, France, Germany, Hong Kong, Iran, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Martinique, Mexico, Monaco, Morocco, Netherlands, Poland, Portugal, Russian Fed., South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, United Arab Emirates, and United Kingdom. | US - 164 units; Outside the US - 333 | clearance family |
| 2015-11-05 | Z-0647-2016 | Class II | Terminated | Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom. | 20 systems | clearance family |
| 2015-11-05 | Z-0648-2016 | Class II | Terminated | Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom. | 48 systems | clearance family |
Regulatory clearances
- 510(k)K142108Substantially equivalent (SESE) · 2014-12-16clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-02-20 | NAI | No action indicated | Brainlab SE | 0 |
| 2025-02-20 | NAI | No action indicated | Brainlab SE | 0 |
| 2016-02-25 | NAI | No action indicated | Brainlab SE | 0 |
| 2016-02-25 | NAI | No action indicated | Brainlab SE | 0 |
| 2013-06-21 | VAI | Voluntary action indicated | Brainlab SE | 3 |
| 2013-06-21 | VAI | Voluntary action indicated | Brainlab SE | 3 |
| 2011-05-27 | NAI | No action indicated | Brainlab SE | 0 |
| 2011-05-27 | NAI | No action indicated | Brainlab SE | 0 |
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