# FDA recall Z-1922-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-04-06.

## Product

Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311

## Reason for recall

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

## Distribution

Worldwide distribution including one unit distributed to Iowa.

## Key facts

- **Recall number:** Z-1922-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-06
- **Report date:** 2020-05-13
- **Termination date:** 2022-09-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1922-2020

## Citation

> AI Analytics. FDA recall Z-1922-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1922-2020. Source: US FDA. Licensed CC0.

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