# FDA recall Z-1583-2025

> **Philips Medical Systems Nederland B.V.** · Class II · device recall initiated 2023-07-20.

## Product

Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

## Reason for recall

Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.

## Distribution

US Nationwide distribution

## Key facts

- **Recall number:** Z-1583-2025
- **Recalling firm:** Philips Medical Systems Nederland B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-20
- **Report date:** 2025-04-30

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Eindhoven, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1583-2025

## Citation

> AI Analytics. FDA recall Z-1583-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1583-2025. Source: US FDA. Licensed CC0.

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