Terumo recalls its Advanced Perfusion System 1 Electronic Patient Gas System (EPGS) due to intermittent failure causing control sliders to disable during calibration. Affected units have specific catalog numbers and UDI codes.
An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs.
Terumo is recalling its Advanced Perfusion System 1 Electronic Patient Gas System (EPGS) because a technical issue can disable the main control system during calibration. This means the gas system can only be controlled by physical knobs, which may lead to unsafe operation during medical procedures.
The EPGS system may experience intermittent failures that cause the central control monitor to disable its digital sliders during startup or calibration. This forces users to rely on physical knobs instead of the electronic controls, which could lead to improper gas delivery and unsafe conditions during surgery.
Healthcare professionals using the Terumo Advanced Perfusion System 1 Electronic Patient Gas System for cardio-pulmonary bypass procedures are most at risk. Patients undergoing surgery with this equipment could face potential complications if the system malfunctions.
Check for the catalog number 801188 and UDI code 00886799000588 on the device. The product is used in cardio-pulmonary bypass procedures and was sold with specific lot/serial numbers listed in the recall notice.
Verify if the system displays a 'blender initialization fault' during startup or calibration attempts.
Reach out to Terumo Cardiovascular Systems Corporation for guidance on next steps.
The recall addresses a technical issue that may cause the system to disable digital controls during calibration, but it does not indicate a risk of serious injury in normal use.
Check if your device has the catalog number 801188 and UDI code 00886799000588. Contact Terumo for specific instructions.
Look for the catalog number 801188 and UDI code 00886799000588 on the device. The product is used in cardio-pulmonary bypass procedures.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1769-2019 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1769-2019 from Terumo. 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.
