# FDA recall Z-1002-2023

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-12-09.

## Product

Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

## Reason for recall

There is potential for the footrest to detach from the patient table during use.    Device intended to visualize anatomical structures by converting an Xray 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. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.

## Distribution

Worldwide distribution

## Key facts

- **Recall number:** Z-1002-2023
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-09
- **Report date:** 2023-01-25

- **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-1002-2023

## Citation

> AI Analytics. FDA recall Z-1002-2023. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1002-2023. Source: US FDA. Licensed CC0.

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