FDA Device recall Z-0282-2016
BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D ve…
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D ve… by Brainlab Ag, citing instances of data sets not being accurately registered to the patient anatomy were observed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0282-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-08 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Brainlab Ag |
| Distribution | n/a |
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
Instances of data sets not being accurately registered to the patient anatomy were observed.
Identifiers
| code_info | Model/catalogue numbers: 19060 AIR ICT S&T W/O G.C. NEUROLOGICA BODYTOM; 19065 MOBILE iCT AUTOMATIC IMAGE REG. CRANIAL…Model/catalogue numbers: 19060 AIR ICT S&T W/O G.C. NEUROLOGICA BODYTOM; 19065 MOBILE iCT AUTOMATIC IMAGE REG. CRANIAL. Potentially affected is the integration of the NeuroLogica BodyTom portable CT scanner for automatic registration with Brainlab Navigation devices (Cranial / ENT version 2.1 and Spine & Trauma 3D versions 2.0 and 2.1) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0282-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.