Recall Z-0282-2016— Brainlab AG
Class II · Terminated
Class II FDA medical device recall by Brainlab AG, initiated 2015-05-08, terminated 2017-02-28. It names one FDA 510(k) clearance: K070106. 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..
- Recalling firm
- Brainlab AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-08
- Terminated
- 2017-02-28
- Firm location
- Feldkirchen, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.