Z-0056-2021Class II

Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and...

Name: Z-0056-2021 Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and...
Creator: Brainlab AG
Published: 2020-08-31
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2020-08-31 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of 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... on 2020-08-31. FDA classified it as Class II and gives the reason as "Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0056-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-31
Posted: 2020-10-06
Terminated: 2021-02-17
Recalling firm: Brainlab, Inc.
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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Root cause tag: software
FDA root cause: Software design
Action: The intraoperative Brainlab Ultrasound Navigation Software does not support the modification of the probes image width, an optional feature of the BK Medical Ultrasound System, resulting in an incorrect display of the depth of the ultrasound overlay by the navigation for non-linear ultrasound probes, with the deviation depending on the probe and the difference between the calibrated and used image width.
Quantity in commerce: 271 units
Distribution: 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.
Product codes and lots: Model/catalogue numbers: 22582 IGSONIC BK MEDICAL SOFTWARE 22582A ULTRASOUND INTEGRATION SW (BK) 22582B ULTRASOUND INTEGRATION SW 22583 LICENSE UPDATE TO IGSONIC SW FOR BK MED 26506 ULTRASOUND SW BK800 SUBSCRIPTION 26506A ULTRASOUND SW BK SUBSCRIPTION 26508A ULTRASOUND SW BK UPDATE UDI: The GTIN for Ultrasound Navigation 1.0 is: 04056481140137 The GTIN for Cranial/ENT Navigation 3.1 is: 04056481132439

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0056-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0056-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-06

Product code HAW

K092467Class IIVectorvision Cranial, Vectorvision ENT, Kolibri Cranial, Kolibri ENT, Cranial Essential, Cranial UnlimitedBrainlab AG / cleared 2010-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)