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