# FDA recall Z-2260-2023

> **Philips North America** · Class II · device recall initiated 2023-04-25.

## Product

Incisive CT Power (China)-Computed Tomography X-Ray System   Model: 728148

## Reason for recall

Metal mounting box on the rotating scanner on rotor  (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down

## Distribution

Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federation Saint Lucia Saint Pierre and Miquelon Saudi Arabia Serbia Slovakia Spain Sweden Taiwan Thailand Tunisia Turkey Turkmenistan United Kingdom Uzbekistan Viet Nam

## Key facts

- **Recall number:** Z-2260-2023
- **Recalling firm:** Philips North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-25
- **Report date:** 2023-08-09

- **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-2260-2023

## Citation

> AI Analytics. FDA recall Z-2260-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2260-2023. Source: US FDA. Licensed CC0.

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