# FDA recall Z-0330-2018

> **Philips Electronics North  America Corporation** · Class II · device recall initiated 2017-10-19.

## Product

CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system    CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography

## Reason for recall

The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and  spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance.

## Distribution

Worldwide Distribution - US Distribution and to the countries of : France, Germany, Luxembourg and New Zealand.

## Key facts

- **Recall number:** Z-0330-2018
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-19
- **Report date:** 2018-01-17
- **Termination date:** 2018-09-20

- **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-0330-2018

## Citation

> AI Analytics. FDA recall Z-0330-2018. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-0330-2018. Source: US FDA. Licensed CC0.

---

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