Recall Z-0056-2021— Brainlab AG

Name: FDA recall Z-0056-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-31

Class II · Terminated

Class II FDA medical device recall by Brainlab AG, initiated 2020-08-31, terminated 2021-02-17. It names one FDA 510(k) clearance: K092467. 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.. Reason: Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width..

Recalling firm: Brainlab AG
Classification: Class II
Status: Terminated
Initiated: 2020-08-31
Terminated: 2021-02-17
Firm location: Munich, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K092467 — VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITEDBrainlab AG·cleared 2010-05-06

K-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

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.