Lower riskMedical device recall · FDA · Published September 13, 2018
Terumo Advanced Perfusion System 1 Gas System Recall: Software Update Missing
Terumo recalls its Advanced Perfusion System 1 Electronic Patient Gas System due to outdated service manual for software version 1.30. Affected units may have safety risks.
“Terumo Advanced Perfusion System 1 Gas System Recall: Software Update Missing.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69867-terumo-advanced-perfusion-system-1-gas-system-recall-software-update. Based on FDA recall #Z-0176-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0176-2019%22&limit=1).
The FDA announced on 2018-09-13 that Terumo Cardiovascular Systems Corporation is recalling its Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188, due to an outdated service manual for software version 1.30. The agency classified the recall as Class II.
How to tell if you have it
Brand: Terumo
Product: Advanced Perfusion System 1 Electronic Patient Gas System
Catalog#: 801188
UDI: 00886799000588
The hazard
The hazard stems from the service manual not being updated when software version 1.30 was released, according to the FDA.
Context
GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since 2017-06-27. Other recent recalls of similar products include GE Medical Systems Portrait Compute V1.2 Software Recall (2026-07-20), Elekta MOSAIQ Oncology System Software Recall (2026-05-21), and BD Pyxis ES Enterprise Server Software Update Issue Recall (2025-12-03).
How to tell if you have this one
Check for the product name 'Terumo Advanced Perfusion System 1 Electronic Patient Gas System' with catalog number 801188. The system was sold with software version 1.30 and UDI 00886799000588.
Brand
Terumo
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your system; if it's 1.30, it may need an update.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 22 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, MI, MN, MO, OH, OR, PA, SC, TN, TX, WA, WI, and Puerto Rico. The products were distributed to the following foreign countries: Antioquia, Australia, Bangkok,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0176-2019 (September 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0176-2019 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.