FDA Medical Device Recalls (openFDA)
Brainlab AG: 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
- Recalling firm
- Brainlab AG
- 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.
- Status
- Terminated
- Initiated
- 2020-08-31
- Posted
- not on file
- Terminated
- 2021-02-17
- Reason
- Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K092467"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 3002619595
- Firm city
- Munich
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28