# FDA recall Z-1265-2021

> **Philips North America Llc** · Class II · device recall initiated 2021-02-22.

## Product

Incisive CT Computed Tomography X-ray System  Model: 728143

## Reason for recall

Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees

## Distribution

US Virgin Island  Foreign:  Australia  Bolivia  China  Germany  Hungary  Indonesia  Italy  Japan  Korea  Korea, Republic of  Latvia  Palestine  Philippines  Romania  Russian Federation  Senegal  Thailand  Uzbekistan

## Key facts

- **Recall number:** Z-1265-2021
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-22
- **Report date:** 2021-03-24
- **Termination date:** 2023-02-09

- **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-1265-2021

## Citation

> AI Analytics. FDA recall Z-1265-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1265-2021. Source: US FDA. Licensed CC0.

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