Ultrasound Navigation Software 1 — Class II medical device recall Z-0056-2021
Terminated recall by Brainlab AG, reported 2020-10-14, distributed nationwide. Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
| Recall number | Z-0056-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Munich, N/A, Germany |
| Recall initiated | 2020-08-31 |
| Classified | 2020-10-06 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2021-02-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CW, CZ, DE, EG, ES, FI, FR, GB, HK, ID, IL, IN, IT, JP, KW, MY, NL, NO, PK, RO, SE, SK, TH, TR, ZA |
| Quantity | 271 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056481132439, 04056481140137 |
| Model numbers | 22582 |
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 for recall
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0056-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.