Terumo recalls its Advanced Perfusion System 1 Electronic Patient Gas System (Catalog #801: 801188) due to intermittent failure causing blender initialization faults during calibration. Affected units may have disabled control sliders.
intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs
Terumo is recalling its Advanced Perfusion System 1 Electronic Patient Gas System (Catalog #801188) because it can fail intermittently during calibration, causing the gas system to become unresponsive. This could lead to improper gas delivery during medical procedures.
The system can fail intermittently during calibration after a 15-minute warm-up period, causing the control sliders to become disabled. This means the gas system can only be controlled by local knobs, potentially leading to improper gas delivery during critical medical procedures.
Healthcare professionals using this system for medical procedures are most at risk. Patients receiving treatment with this system could be affected if the device malfunctions.
Check for the product name 'Terumo Advanced Perfusion System 1 Electronic Patient Gas System' with Catalog #801188. The serial number (S/N) starts with 01751 and the UDI is 00886799000588.
Ensure the control sliders on the Central Control Monitor are functional before use.
Confirm the Catalog #801188 and serial number starting with 01751 for affected units.
The recall is for a potential intermittent failure during calibration that could disable control sliders, but the device is not immediately dangerous if used correctly.
Check for the product name 'Terumo Advanced Perfusion System 1 Electronic Patient Gas System' with Catalog #801188 and serial number starting with 01751.
The recall does not specify a remedy, so contact Terumo directly for guidance.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-2350-2021 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-2350-2021 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.
