Z-0241-2023 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 23, 2022
- Initiation Date
- October 17, 2022
- Termination Date
- May 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product 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
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
Distribution Pattern
US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.
Code Information
UDI: 00724995180256 Serial Numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002