# FDA recall Z-1584-2023

> **Philips North America Llc** · Class II · device recall initiated 2023-03-17.

## Product

Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333

## Reason for recall

Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.

## Distribution

Worldwide - US Nationwide distribution including in the states of States: AZ, IN, MA, MD, MN, NY, OH, PA, and TX. The countries of Australia, Austria, China, Czech Republic, Denmark, France, Germany, Israel, Japan, Malaysia, Netherlands, Norway, Palestine, Panama, South Korea, Spain, Switzerland, Thailand, United Kingdom.

## Key facts

- **Recall number:** Z-1584-2023
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-17
- **Report date:** 2023-05-24

- **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-1584-2023

## Citation

> AI Analytics. FDA recall Z-1584-2023. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1584-2023. Source: US FDA. Licensed CC0.

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