Use caution Medical device recall · FDA · Published October 17, 2018

Terumo EPGS Gas System Recall: Intermittent Failure May Disable Control Sliders

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1769-2019Medical device Terumo ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmTerumo Cardiovascular Systems Corporation6200 Jackson Rd · Ann Arbor, MI 48103-9586

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/69607-terumo-epgs-gas-system-recall-intermittent-failure-may-disable-control.

Source Summary by GovInfoNow · govinfonow.com/recall/69607-terumo-epgs-gas-system-recall-intermittent-failure-may-disable-control · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1769-2019

Cite this page

“Terumo EPGS Gas System Recall: Intermittent Failure May Disable Control Sliders.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69607-terumo-epgs-gas-system-recall-intermittent-failure-may-disable-control. Based on FDA recall #Z-1769-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1769-2019%22&limit=1).

The FDA announced on 2018-10-17 that Terumo Cardiovascular Systems Corporation is recalling the Terumo Advanced Perfusion System 1 Electronic Patient Gas System due to an intermittent failure disabling central control. The hazard involves a blender initialization fault that restricts operation to local knobs only. This voluntary Class II recall affects 72 units distributed in the U.S., Canada, Mexico, and South Korea.

How to tell if you have it

Brand: Terumo
Product: Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender
Catalog #: 801188
UDI: 00886799000588
Lot/Serial numbers: 01338, 01339, 01340, 01341, 01342, 01349, 01350, 01351, 01352, 01353, 01354, 01355, 01356, 01357, 01358, 01360, 01361, 01362, 01363, 01365, 01366, 01367, 01369, 01370, 01371, 01372, 01373, 01374, 01375, 01376, 01377, 01378, 01379, Lot/Serial 01380, 01381, 01382, 01383, 01384, 01385, 01386, 01387, 01388, 01389, 01394, 01395, 01396, 01397, 01398, 01405, 01406, 01407, 01408, 01410, 01411, 01413, 01414, 01415, 01416, 01418, 01420, 01421, 01422, 01423, 01424, 01425, 01426, Lot/Serial 01427, 01428, 01429, 01430, 01431, 01432, 01434, 01435, 1718, 2317, 4417, 9999

The hazard

An intermittent failure causes a blender initialization fault upon start-up or during an EPGS calibration attempt. This fault disables the Central Control Monitor control sliders, meaning the gas system can only be controlled by the local control knobs.

Context

GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since 2017-06-27. Recent brand recalls include a 2025-05-28 Terumo CDI OneView BPM Probe Recall for temperature inaccuracy risk, a 2025-03-03 Terumo CDI OneView Hematocrit Probe Recall for dashed SO2 values triggering false alarms, and a 2024-02-20 Terumo Cardiovascular Procedure Kits recall for high crack check valve risk of myocardial damage. Other recent recalls of similar products include the GE Healthcare Carestation Anesthesia System Power Board Recall (2025-11-14), the Olympus UHI-4 Insufflation Unit Recall (2026-06-16), and the GE Allia Moveo X-ray System Recall (2026-04-20).

How to tell if you have this one

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.

Brand
Terumo
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Status
Verify if the system displays a 'blender initialization fault' during startup or calibration attempts.
Contact Manufacturer
Reach out to Terumo Cardiovascular Systems Corporation for guidance on next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 13 states.

FDA distribution: “Distribution US nationwide, including CA, CT, IL, IN, KY, MI, MN, MO, MT, NM, NY, OH, and WI. Foreign distribution to Canada, Mexico, and South Korea.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Connecticut, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, Montana, New Mexico, New York, Ohio, Wisconsin.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

Oct 17, 2018Firm started the recall
Jun 11, 2019FDA classified it Class II
Jun 19, 2019Published in FDA’s Enforcement Report
Apr 30, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/69607-terumo-epgs-gas-system-recall-intermittent-failure-may-disable-control">Terumo EPGS Gas System Recall: Intermittent Failure May Disable Control Sliders (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1769-2019 (October 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1769-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.