Company: Brainlab AG
Date of Enforcement Report: 10/14/2020
Class II

PRODUCT

Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

Recall Number: Z-0056-2021

REASON

Brainlab Ultrasound Navigation Software does not support the modification of the probe’s image width.

RECALLING FIRM/MANUFACTURER

Brainlab AG on 8/31/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

271 units

DISTRIBUTION

U.S. Nationwide and International