# FDA recall Z-1479-2023

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-11-23.

## Product

Luminos Agile Max (VE10, VF10, VF11)

## Reason for recall

Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.

## Distribution

US Nationwide - Worldwide Distribution

## Key facts

- **Recall number:** Z-1479-2023
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-23
- **Report date:** 2023-05-31

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1479-2023

## Citation

> AI Analytics. FDA recall Z-1479-2023. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-1479-2023. Source: US FDA. Licensed CC0.

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