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U.S. Department of Health and Human Services

Class 2 Device Recall GI4000 Electrosurgical Unit

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  Class 2 Device Recall GI4000 Electrosurgical Unit see related information
Date Initiated by Firm October 17, 2022
Date Posted November 16, 2022
Recall Status1 Open3, Classified
Recall Number Z-0241-2023
Recall Event ID 91020
510(K)Number K192265  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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
Code Information UDI: 00724995180256 Serial Numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact SAME
440-392-7601
Manufacturer 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
FDA Determined
Cause 2		 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 Bailey, Product Manager at 440-358-6075 or your local STERIS Representative will provide Customer Notification Letters to all Customers who purchased affected GI4000 Electrosurgical Units. STERIS will request that all affected GI4000 Electrosurgical Units be returned to complete the correction. While the units are being reworked, Customers will be provided with a loaner unit. Cintron Medical will be changing the receiving inspection plan for the PCBA. The inspection plan will have a step to verify the orientation of the diodes.
Quantity in Commerce 5 units
Distribution US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = United States Endoscopy Group, Inc
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