Ultrasound Navigation Software 1.0 and Ultrasound… recallZ-0056-2021 · Brainlab AG · initiated Aug 31, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Brainlab AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0056-2021
- Status
- Terminated
- Initiated by the company
- Aug 31, 2020
- Recalling firm
- Brainlab AG
- Quantity
- 271 units
- Product code
- HAW
- FDA submissions
- K092467
- 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 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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Cranial/ENT 3.1Brainlab SE · Neurological Stereotaxic Instrument1 recall105 reports
- Ultrasound Navigation 1.0Brainlab SE · Neurological Stereotaxic Instrument1 recall0 reports
Other devices under the same FDA submission
11 devices cleared under K092467 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Cranial 3.1Brainlab SE · Neurological Stereotaxic Instrument37 reports
- Cranial 2.1Brainlab SE · Neurological Stereotaxic Instrument27 reports
- Navigation SW Cranial EM 1.1Brainlab SE · Neurological Stereotaxic Instrument21 reports
- Cranial Navigation System Navigation 4.0Brainlab SE · Neurological Stereotaxic Instrument14 reports
- Navigation Software Cranial 3.5Brainlab SE · Neurological Stereotaxic Instrument7 reports
- Navigation Software Cranial 3.0Brainlab SE · Neurological Stereotaxic Instrument3 reports
- Ent 3.1Brainlab SE · Neurological Stereotaxic Instrument1 report
- Ent 2.1Brainlab SE · Neurological Stereotaxic Instrument1 report
- Reference Star Iop Imaging 19145-01Brainlab SE · Neurological Stereotaxic Instrument1 report
- Dispos. Clip-On Remote Control 53151Brainlab SE · Neurological Stereotaxic Instrument1 report
- Registration Software Cranial 3.5Brainlab SE · Neurological Stereotaxic Instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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