Steris recalls GI4000 Electrosurgical Units with specific serial numbers due to potential power regulator failure during surgery, causing procedural delays. Affected units may need repair or replacement.
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
Steris is recalling certain GI4000 Electrosurgical Units because faulty wiring could cause power loss during surgery, leading to procedural delays. This is a serious issue for medical staff using these devices in operating rooms.
Two electronic diodes on the controller board are installed in the wrong direction, which may cause the power regulator to fail. If this happens during surgery, it could lead to a temporary loss of power, causing delays in the procedure.
Healthcare professionals using the GI4000 Electrosurgical Units in operating rooms are most at risk. Patients undergoing surgery with these units could experience procedural delays if the power regulator fails.
Check the serial numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002. The units were sold with model numbers G1110001 and UDI 00724995180256.
Verify your unit's serial number against the list: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002.
Steris will provide a repair kit to fix the diode issue if your unit is affected.
Steris identified that two electronic diodes on the controller board are installed in the reverse orientation, which may cause premature wear of the power regulator and lead to power loss during surgery.
If the regulator fails during a patient procedure, it could cause a procedural delay, but this is not expected to cause serious injury.
No, but you should check your serial number and contact Steris for repair if it's on the list. The hazard does not cause immediate danger.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0241-2023 — Steris Steris Hello, I own a Steris that is covered by recall Z-0241-2023 from Steris. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
