GI4000 Electrosurgical Unit recalled due to power regulator failure risk
Steris recalls 5 GI4000 Electrosurgical Units with defective diode components that may cause power loss during endoscopic procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with potential for power loss during patient procedures. No injuries or illnesses have been reported. The hazard is a manufacturing defect that creates a theoretical risk of procedural disruption, meeting the criteria for High severity without reported harm.
Plain-English summary
Steris Corporation is recalling 5 GI4000 Electrosurgical Units due to a manufacturing defect in the controller circuit board. Two electronic diode components (D1 and D4) were placed in reverse orientation during manufacturing, which may cause premature wear of the power regulator.
If the power regulator fails during a patient procedure, the unit could lose all power output, resulting in a procedural delay. The affected units have the following serial numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002.
The units were distributed nationwide in Arizona, Illinois, Tennessee, and Virginia. Healthcare facilities that have received these units should stop using them immediately and contact Steris Corporation for replacement or repair instructions.
The recalled product
- 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
- Manufacturer
- Steris Corporation
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI: 00724995180256 Serial Numbers: 0032-0822-003
- 0032-0622-009
- 0032-0922-001
- 0032-0822-001
- and 0032-0082-002
Distribution
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