GI4000 Electrosurgical Unit - intended to deliver… recallZ-0241-2023 · Steris Corporation · initiated Oct 17, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Component design/selection
What the company is doing
STERIS issued Urgent Medical Device Field Correction on 10/17/22. Letter states reason for recall, health risk and action to take: All affected Customers will be contacted by a STERIS Representative to arrange the return of their GI4000 Electrosurgical Units to complete the correction. User Action Please ensure the following steps are completed: 1. Work with STERIS Representative to arrange pick up of your GI4000 Electrosurgical Unit. 2. STERIS will repair or replace the GI4000 Electrosurgical Unit for your facility. If you have questions regarding this matter, please contact Jennifer Bailey, Product Manager at 440-358-6075 or your local STERIS Representative will provide Customer Notification Letters to all Customers who purchased affected GI4000 Electrosurgical Units. STERIS will request that all affected GI4000 Electrosurgical Units be returned to complete the correction. While the units are being reworked, Customers will be provided with a loaner unit. Cintron Medical will be changing the receiving inspection plan for the PCBA. The inspection plan will have a step to verify the orientation of the diodes.
Recall details
- Recall number
- Z-0241-2023
- Status
- Terminated
- Initiated by the company
- Oct 17, 2022
- Posted by the FDA
- Nov 16, 2022
- Recalling firm
- Steris Corporation
- Quantity
- 5 units
- Product code
- GEI
- FDA submissions
- K192265
- Distribution
- US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.
Product description
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
Code information (models, lots, serial numbers)
UDI: 00724995180256 Serial Numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA gi4000US Endoscopy · Electrosurgical, cutting & coagulation & accessories1 recall8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page