GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coag
FDA device recall Z-0241-2023 · posted 2022-11-16 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- 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
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 5 units
- Distribution
- US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.
- Date initiated
- 2022-10-17
- Date posted
- 2022-11-16
- Date terminated
- 2024-05-28
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| gi-4000 Electrosurgical Generator (K192265) | United States Endoscopy Group, Inc. | 2020-05-21 |