BRAINLAB SE
78 adverse events · 38 recalls · 8 inspections · 1 clearances · aggregated across 4 source records
Scorecard
Events per device across the 1,042-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.070 ▼
73 in the last 12 months
Higher volume than 92% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
1,042 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Spine & Trauma 3D Navigation | 1,5 | OLO | 04056481142025 | 125 |
| Spine & Trauma Navigation | 2.0 | OLO | 04056481143954 | 104 |
| Cranial/ENT | 3.1 | HAW | 04056481132439 | 100 |
| Navigation Software Spine & Trauma 3D | 2.6 | HAW OLO | 04056481106591 | 82 |
| CRANIAL NAVIGATION | 39 | |||
| Spine &Trauma Navigation | 3.0 | OLO | 04056481144906 | 39 |
| Cranial Navigation | 4.1 | HAW | 04056481143848 | 19 |
| Navigation SW Cranial EM | 1.1 | HAW | 04056481132422 | 19 |
| Cranial Navigation System Navigation | 4.0 | HAW | 04056481141356 | 16 |
| Alignment Software Cranial | 2.0 | HAW | 04056481144487 | 15 |
| Cranial | 3.1 | HAW | 04056481000479 | 12 |
| Exactrac | 6.2 | IYE | 04056481000264 | 10 |
| Navigation Software Cranial | 3.5 | HAW | 04056481140663 | 8 |
| Cranial | 2.1 | HAW | 04056481000493 | 7 |
| Exactrac | 6.5 | IYE | 04056481138400 | 7 |
| Brainlab Elements Image Fusion | 4.0 | JAK LLZ | 04056481140816 | 6 |
| Couchmount Siemens | 40100-4A | IYE | 04056481004248 | 6 |
| Exactrac | 48371 | IYE | 04056481006952 | 6 |
| Exactrac | 48370 | IYE | 04056481006945 | 6 |
| ExacTrac Dynamic | 1.1 | IYE | 04056481143978 | 5 |
| RT QA Element | 1.0 | MUJ | 04056481007119 | 5 |
| Spine & Trauma 3D Navigation | 1.0 | HAW OLO | 04056481140328 | 5 |
| Dose Review | 1.0 | MUJ | 04056481000585 | 4 |
| Dose Review Running As Registry Uploader | 1 | MUJ | 04056481000752 | 4 |
| ExacTrac Vero | 3.5 | IYE | 04056481132446 | 4 |
| Multiple Brainmets Srs | 1.0 | MUJ | 04056481000578 | 4 |
| Physics Administration | 5.0 | MUJ | 04056481131500 | 4 |
| Cirq Arm System 2.0 | 56500 | HAW OLO | 04056481143961 | 3 |
| ExacTrac Dynamic | 2.0 | IYE | 04056481144609 | 3 |
| ExacTrac Vero | 3.6 | IYE | 04056481000769 | 3 |
Showing 1–30 of 1,042Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3002619595 | BRAINLAB SE | Munich Bavaria, DE | NAI |