# FDA recall Z-0241-2022

> **Philips Healthcare** · Class II · device recall initiated 2021-09-22.

## Product

CombiDiagnost R90 is multi-functional general R/F systems.

## Reason for recall

The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards.  This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification  statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0241-2022
- **Recalling firm:** Philips Healthcare
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-22
- **Report date:** 2021-12-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0241-2022

## Citation

> AI Analytics. FDA recall Z-0241-2022. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0241-2022. Source: US FDA. Licensed CC0.

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