Brainlab AG Olof-palme-str. 9 Munich Germany 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Brainlab AG Olof-palme-str. 9 Munich Germany
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Brainlab AG Olof-palme-str. 9 Munich Germany is recalling Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3. due to Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026