# FDA recall Z-0919-2022

> **GE Healthcare, LLC** · Class II · device recall initiated 2022-03-16.

## Product

MUSE Cardiology Information System, Model Numbers:  a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008

## Reason for recall

Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.

## Distribution

US and Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, England, France, Germany, Ireland, Italy, Korea, Malaysia, Netherlands, Norway, Poland, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Turkey

## Key facts

- **Recall number:** Z-0919-2022
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-16
- **Report date:** 2022-04-20
- **Termination date:** 2026-05-04

- **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-0919-2022

## Citation

> AI Analytics. FDA recall Z-0919-2022. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/Z-0919-2022. Source: US FDA. Licensed CC0.

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