# FDA recall Z-0576-2024

> **Philips North America Llc** · Class II · device recall initiated 2022-03-29.

## Product

The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

## Reason for recall

Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.

## Distribution

Domestic: AL, AR, AZ, CA, FL, GA, HI, IL, IN, KY, LA, MD, ME, MI, MS, NC, NJ, NM, NY, OH, OK, PA, RI, TN, TX; Foreign: Albania, Argentina, Australia, Austria, Bolivia, Bosnia-Herzegovina , Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kenya, Kosovo, Lao People's Democratic Republic, Latvia, Lebanon, Moldova, Morocco, Netherlands, Palestine, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russian Federation, Saint Lucia, Saint Pierre and Miquelon, Sint Maarten , South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Viet Nam.

## Key facts

- **Recall number:** Z-0576-2024
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-03-29
- **Report date:** 2023-12-27

- **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-0576-2024

## Citation

> AI Analytics. FDA recall Z-0576-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0576-2024. Source: US FDA. Licensed CC0.

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