GI4000 Electrosurgical Unit - intended to deliver recall
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without…
Why was GI4000 Electrosurgical Unit - intended to deliver recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00724995180256 Serial Numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002
- Product
- GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without…
- Recalling firm
- Steris Corporation
- Quantity
- 5 units
- Distribution
- US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.
- Recall date
- November 23, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)