# FDA recall Z-1853-2021

> **Abbott Laboratories Inc. (St Jude Medical)** · Class II · device recall initiated 2021-05-05.

## Product

v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123.  The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.

## Reason for recall

Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

## Distribution

US Nationwide distribution in the states of MI, KS, MO, TX.

## Key facts

- **Recall number:** Z-1853-2021
- **Recalling firm:** Abbott Laboratories Inc. (St Jude Medical)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-05
- **Report date:** 2021-06-23
- **Termination date:** 2024-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1853-2021

## Citation

> AI Analytics. FDA recall Z-1853-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1853-2021. Source: US FDA. Licensed CC0.

---

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