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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0241-2023 |
| Event ID | 91020 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia. |
| Quantity | 5 units |
| Recall Reason | 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 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 Classification | 20221123 |
| Device Code Info | UDI: 00724995180256 Serial Numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002 |
| Center Classification Date | 20221116 |
| Recall Initiation Date | 20221017 |
| Recalling Firm | Steris Corporation |
| Initial Notification | Letter |
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