# FDA recall Z-2656-2023

> **GE Medical Systems China Co., Ltd.** · Class II · device recall initiated 2023-09-08.

## Product

F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

## Reason for recall

There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Zealand, Oman, Poland, Qatar, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-2656-2023
- **Recalling firm:** GE Medical Systems China Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-08
- **Report date:** 2023-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wuxi, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2656-2023

## Citation

> AI Analytics. FDA recall Z-2656-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2656-2023. Source: US FDA. Licensed CC0.

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