# FDA recall Z-2750-2020

> **GE Healthcare, LLC** · Class II · device recall initiated 2020-06-22.

## Product

CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.

## Reason for recall

CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of MT, NC, TX and WI. The countries of Australia, Austria, Bahrain,Belgium, Bolivia, Brazil ,Canada, Chile, Check Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Russia, Saudi Arabia, Singapore, Saint Martin, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-2750-2020
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-22
- **Report date:** 2020-08-12
- **Termination date:** 2024-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2750-2020

## Citation

> AI Analytics. FDA recall Z-2750-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2750-2020. Source: US FDA. Licensed CC0.

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