# FDA recall Z-0052-2019

> **Oridion Medical 1987 Ltd.** · Class II · device recall initiated 2018-07-31.

## Product

Capnostream20 (INTL) M REFURBISHED, CS78654

## Reason for recall

The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.

## Distribution

The products were distributed US nationwide and Puerto Rico.    The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.

## Key facts

- **Recall number:** Z-0052-2019
- **Recalling firm:** Oridion Medical 1987 Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-31
- **Report date:** 2018-10-10
- **Termination date:** 2022-09-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jerusalem, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0052-2019

## Citation

> AI Analytics. FDA recall Z-0052-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0052-2019. Source: US FDA. Licensed CC0.

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