Class II — Brainlab AG
| Recalling firm | Brainlab Ltd. |
|---|---|
| Registered facility | Brainlab Ltd. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width. |
| 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. |
| 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, Norwa… |
| Initiated | 2020-08-31 |
| Classified | 2020-10-06 |
| Terminated | 2021-02-17 |
| Recall number | Z-0056-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Brainlab AG (Z-0056-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86438/
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