Reported Nov 23, 2022 · Terminated
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and…
Steris Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834
Is this the product you have?
- 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
- Lot codes and dates
- UDI00724995180256
- Serial Numbers
0032-0822-0030032-0622-0090032-0922-0010032-0822-001and 0032-0082-002
- Amount recalled
- 5 units
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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