Device 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.
Z-0282-2016
Product summary
- Firm
- Brainlab AG
- Event
- Event 71248
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 systems total (10 in U.S., 2 in Australia)
- Official record key
device-enforcement:Z-0282-2016
Official wording
Reason: Instances of data sets not being accurately registered to the patient anatomy were observed.
Code information: 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)
Distribution pattern: Distributed in the US and Australia.
Derived failure modes
-
Unknown
Instances of data sets not being accurately registered to the patient anatomy were observed.