# FDA recall Z-1589-2023

> **Philips North America** · Class II · device recall initiated 2023-03-03.

## Product

CombiDiagnost R90 R1.1

## Reason for recall

Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug  Administration (FDA).

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-1589-2023
- **Recalling firm:** Philips North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-03
- **Report date:** 2023-05-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1589-2023

## Citation

> AI Analytics. FDA recall Z-1589-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1589-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*