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.
Reported: November 25, 2015 Initiated: May 8, 2015 #Z-0282-2016
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.
Details
- Recalling Firm
- Brainlab AG
- Units Affected
- 12 systems total (10 in U.S., 2 in Australia)
- Distribution
- Distributed in the US and Australia.
- Location
- Feldkirchen, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Brainlab AG. Units affected: 12 systems total (10 in U.S., 2 in Australia).
Why was this product recalled? ▼
Instances of data sets not being accurately registered to the patient anatomy were observed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2015. Severity: Moderate. Recall number: Z-0282-2016.
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