Use cautionMedical device recall · FDA · Published August 28, 2018
Terumo Advanced Perfusion System Platform Recall: Electrical Short Risk
Terumo recalls specific models of Advanced Perfusion System Platform for cardiopulmonary bypass use due to potential electrical short from improperly torqued screws. Affected units may need repair or replacement.
Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system
Take action
Contact the company
📍Recalling firmTerumo Cardiovascular Systems Corporation6200 Jackson Rd · Ann Arbor, MI 48103-9586
“Terumo Advanced Perfusion System Platform Recall: Electrical Short Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69961-terumo-advanced-perfusion-system-platform-recall-electrical-short-risk. Based on FDA recall #Z-3243-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3243-2018%22&limit=1).
The FDA announced on Aug. 28, 2018, that Terumo Cardiovascular Systems Corporation voluntarily recalled its Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures due to a potential electrical short hazard. The recall affects 10 units distributed nationwide and in Mexico, Belgium, Canada, India, Indonesia, Singapore, South Korea, and Vietnam.
How to tell if you have it
Brand: Terumo
Product: Terumo 220/240V AC, Advanced Perfusion System Platform (APS)
Spare Parts: ASSEMBLY POWER MANAGER POD APS S/N: 03097, 03099, 03100, 03101, 03113, 03114, 03115, 03143, 03155, 03167, 03264
The hazard
Screws on the Terumo Advanced Perfusion System 1 Power Manager Board were not torqued to specification. A screw that has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system.
Context
GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since June 27, 2017. Other recent recalls of similar products include Philips Allura Xper FD10C Medical System Recall (Dec. 15, 2025), Philips Allura Xper FD10F Medical System Recall (Dec. 15, 2025), and GE Allia Moveo X-ray System Recall (April 20, 2026).
How to tell if you have this one
Check for catalog number 801764 on the device. Affected units have serial numbers starting with 1522 through 1544 or specific spare parts numbers listed in the recall notice.
Brand
Terumo
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam
Recall number
Product, codes & lots
Quantity
Z-3242-2018
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763; Serial Numbers: 0386 1481 1497 1509 1526 1529 1531 1532 1535 1536 1537 1538 1539 1540 1541 1542 1543 1544 1545 1546 1548 1549 1550 1551 1552 1553 1554 1555 1556 1557 1558 1561 1562 1563 1564 1565 1566 1570 1597 1612 1630 1631 1640 1641 1649 1547 1560 1559 1567 Spare Parts: 870509 ASSEMBLY POWER MANAGER POD APS S/N: 03130 , 03308
47 units
Z-3243-2018
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764; Serial Numbers: 1522 1523 1524 1525 1528 1530 1526 1527 1532 1544 Spare Parts: 870509 ASSEMBLY POWER MANAGER POD APS S/N: 03097 03099 03100 03101 03113 03114 03115 03143 03155 03167 03264
10 units
Based on the official FDA remedy
What to do — step by step
Check Device Details
Identify the catalog number and serial numbers listed in the recall notice to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 20 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-3243-2018 (August 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3243-2018 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.