# FDA recall Z-0583-2025

> **Philips North America Llc** · Class II · device recall initiated 2024-11-16.

## Product

Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.

## Reason for recall

Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

## Distribution

Worldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-0583-2025
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-16
- **Report date:** 2024-12-11

- **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-0583-2025

## Citation

> AI Analytics. FDA recall Z-0583-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0583-2025. Source: US FDA. Licensed CC0.

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