# FDA recall Z-1055-2024

> **PHILIPS MEDICAL SYSTEMS** · Class II · device recall initiated 2023-12-13.

## Product

Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.

## Reason for recall

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

## Distribution

Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia,  Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.

## Key facts

- **Recall number:** Z-1055-2024
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-13
- **Report date:** 2024-02-14

- **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-1055-2024

## Citation

> AI Analytics. FDA recall Z-1055-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1055-2024. Source: US FDA. Licensed CC0.

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