Steris Corporation: 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 e

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

Details from the source

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. Quantity: 5 units Lot/code info: UDI: 00724995180256 Serial Numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002

UPC codes

00724995180256

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.