FDA-Device2022-11-23Class II
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
Hazard
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
Sold states
US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.
Affected count
5 units
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0241-2023More Steris Corporation recalls
- FDA-Device2026-06-24Steris HarmonyAIR A-Series Surgical Lighting System recalled for detachable control buttons
- FDA-Device2026-06-24Steris HarmonyAIR A-Series Surgical Lighting System recalled for paint delamination
- FDA-Device2026-06-24Steris ALYON Surgical Lighting System recalled for detachable control buttons
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