# FDA recall Z-2317-2021

> **Philips North America Llc** · Class II · device recall initiated 2021-06-08.

## Product

728332 IQon Spectral CT-Computed Tomography X-ray system

## Reason for recall

When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

## Distribution

US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.

## Key facts

- **Recall number:** Z-2317-2021
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-08
- **Report date:** 2021-08-25
- **Termination date:** 2023-08-10

- **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-2317-2021

## Citation

> AI Analytics. FDA recall Z-2317-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2317-2021. Source: US FDA. Licensed CC0.

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