# FDA recall Z-0241-2023

> **Steris Corporation** · Class II · device recall initiated 2022-10-17.

## Product

GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications.    MODEL #(s): G1110001

## Reason for recall

Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result

## Distribution

US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.

## Key facts

- **Recall number:** Z-0241-2023
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-10-17
- **Report date:** 2022-11-23
- **Termination date:** 2024-05-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mentor, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0241-2023

## Citation

> AI Analytics. FDA recall Z-0241-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0241-2023. Source: US FDA. Licensed CC0.

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