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Steris Corporation Recall 91020

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

Steris Corporation Recall 91020 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0241-2023
Event ID91020
Event DescriptionGI4000 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
Product TypeDevices
DistributionUS Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.
Quantity5 units
Recall ReasonTwo 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 regulator s failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result
Device Classification20221123
Device Code InfoUDI: 00724995180256 Serial Numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002
Center Classification Date20221116
Recall Initiation Date20221017
Recalling FirmSteris Corporation
Initial Notification Letter
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