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Steris Corporation recalls GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coag
Recalled November 23, 2022 · FDA recall Z-0241-2023 · Steris
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 · FDA Class II
Units
5 units
Sold at
US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.
Description
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
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
Manufacturer(s)
Steris Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →