# FDA recall Z-1332-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-01-08.

## Product

Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.

## Reason for recall

Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in  collision control creating risk of collision with obstacles or persons when the operator uses the override function.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1332-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-08
- **Report date:** 2020-02-26
- **Termination date:** 2022-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1332-2020

## Citation

> AI Analytics. FDA recall Z-1332-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1332-2020. Source: US FDA. Licensed CC0.

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