BrainLAB Image Guided Surgery — Class II medical device recall Z-0282-2016
Terminated recall by Brainlab AG, reported 2015-11-25. Instances of data sets not being accurately registered to the patient anatomy were observed.
| Recall number | Z-0282-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, N/A, Germany |
| Recall initiated | 2015-05-08 |
| Classified | 2015-11-17 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-02-28 |
| Countries outside the US | AU |
| Quantity | 12 systems |
| Model numbers | 19060AIR |
Product
BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.
Reason for recall
Instances of data sets not being accurately registered to the patient anatomy were observed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0282-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.