Brainlab AG recalls Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Prod

Recalled October 14, 2020 · FDA recall Z-0056-2021 · Brainlab AG

Hazard

Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width. · FDA Class II

Units

271 units

Sold at

Worldwide distribution - US Nationwide distribution including in the states of Illinois, Massachusetts, Texas, California, Idaho, Missouri, Oregon, Connecticut and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Curacao, Czech Republic, Egypt, Finland, France, Germany, Switzerland, Netherlands, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kuwait, Malaysia, Myanmar, Norway, Pakistan, Romania, Slovakia, South Africa, Spain, Sweden, Thailand, Turkey and United Kingdom.

Description

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

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.

Manufacturer(s)

Brainlab AG

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →