# FDA recall Z-1273-2021

> **Philips Healthcare (Suzhou) Co., Ltd.** · Class II · device recall initiated 2021-02-24.

## Product

Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.

## Reason for recall

Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of KY, FL, St. Croix, and the countries of Australia, Bolivia, China, Germany, Hungary, Italy, Japan, Republic of Korea, Latvia, Palestine, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Spain, Sweden, Thailand, Uzbekistan.

## Key facts

- **Recall number:** Z-1273-2021
- **Recalling firm:** Philips Healthcare (Suzhou) Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-24
- **Report date:** 2021-03-24
- **Termination date:** 2023-02-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Suzhou, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1273-2021

## Citation

> AI Analytics. FDA recall Z-1273-2021. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-1273-2021. Source: US FDA. Licensed CC0.

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