# FDA recall Z-1165-2023

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-12-21.

## Product

Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for  radiographic and fluoroscopic studies  Model Number: 10762472

## Reason for recall

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1165-2023
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-21
- **Report date:** 2023-03-01

- **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-1165-2023

## Citation

> AI Analytics. FDA recall Z-1165-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1165-2023. Source: US FDA. Licensed CC0.

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