Recall Z-0241-2023 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
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 endoscopic applications. MODEL #(s): G1110001
| Date | Nov 16, 2022 (initiated Oct 17, 2022) |
| Status | Terminated |
| 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 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 |
| Root cause | Component design/selection |
| Action | STERIS issued Urgent Medical Device Field Correction on 10/17/22. Letter states reason for recall, health risk and action to take: All affected Customers will be contacted by a STERIS Representative to arrange the return of their GI4000 Electrosurgical Units to complete the correction. User Action Please ensure the following steps are completed: 1. Work with STERIS Representative to arrange pick up of your GI4000 Electrosurgical Unit. 2. STERIS will repair or replace the GI4000 Electrosurgical Unit for your facility. If you have questions regarding this matter, please contact Jennifer |
| Quantity | 5 units |
| Distribution | US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192265 | gi-4000 Electrosurgical Generator United States Endoscopy Group, Inc., May 21, 2020 |