FDA Device recall Z-0056-2021
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended…
- FDA Device
- Class II
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class II 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… by Brainlab Ag, citing brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0056-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-31 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Brainlab Ag |
| Distribution | US |
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.
Identifiers
| code_info | Model/catalogue numbers: 22582 IGSONIC BK MEDICAL SOFTWARE 22582A ULTRASOUND INTEGRATION SW (BK) 22582B ULTRASOUND I…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0056-2021%22
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