Recall Z-0282-2016 ยท HAW Neurological Stereotaxic Instrument
Brainlab AG
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.
| Date | Nov 17, 2015 (initiated May 8, 2015) |
| Status | Terminated |
| Reason | Instances of data sets not being accurately registered to the patient anatomy were observed. |
| Root cause | Nonconforming Material/Component |
| Action | A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated April 30, 2015 was sent to all direct accounts (customers). The letters included instructions for customers to: To reduce the risk of an inappropriate automatic registration, Brainlab, in cooperation with NeuroLogica, has developed an improved integration- and verification-workflow to be followed, and additionally wants to re-iterate important use instructions, as described below and specified in detail in the Appendix of this document. When using Brainlab's navigation software to perform automatic registration of CT image data sets |
| Quantity | 12 systems total (10 in U.S., 2 in Australia) |
| Distribution | Distributed in the US and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070106 | VV FLUORO 3D Brainlab AG, Apr 23, 2007 |