# FDA recall Z-2792-2020

> **Brainlab AG** · Class II · device recall initiated 2020-07-16.

## Product

BRAINLAB Curve;  Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905  UDI (GTIN) for Curve: 04056481138011

## Reason for recall

Incorrect manufacturer calibration

## Distribution

USA: CA, TX, RI    OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain

## Key facts

- **Recall number:** Z-2792-2020
- **Recalling firm:** Brainlab AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-16
- **Report date:** 2020-08-19
- **Termination date:** 2021-07-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2792-2020

## Citation

> AI Analytics. FDA recall Z-2792-2020. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-2792-2020. Source: US FDA. Licensed CC0.

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