# FDA recall Z-0544-2025

> **Philips North America Llc** · Class II · device recall initiated 2024-11-04.

## Product

Mammotrak Interventional Coil 3.0T

## Reason for recall

Potential safety issue where a patient may be harmed while preparing for or during a scan.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0544-2025
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-04
- **Report date:** 2024-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0544-2025

## Citation

> AI Analytics. FDA recall Z-0544-2025. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-0544-2025. Source: US FDA. Licensed CC0.

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