Terumo Advanced Perfusion System 1 recallZ-0176-2019 · Terumo Cardiovascular Systems Corporation · initiated Sep 13, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The service manual was not updated at the time of the release of software version 1.30.
FDA root cause category: Error in labeling
What the company is doing
Urgent Medical Device Recall notification letters dated 8/27/18 were sent to customers.
Recall details
- Recall number
- Z-0176-2019
- Status
- Terminated
- Initiated by the company
- Sep 13, 2018
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 152
- Product code
- DTQ
- FDA submissions
- K172220
- 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, Bangladesh, Belgium, Canada, Chile, China, Columbia, Dominican Republic, Ecuador, El Salvador, France, Germany, Guatemala, India, Indonesia, Japan, Korea, Kuwait, Malaysia, Metro Manilla, Mexico, New Delhi, New Zealand, Panama, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Thailand, and Vietnam.
Product description
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Code information (models, lots, serial numbers)
All systems. UDI 00886799000588
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Terumo® Advanced Perfusion System 1 801188Terumo Cardiovascular Systems Corporation · Console, Heart-Lung Machine, Cardiopulmonary Bypass3 recalls447 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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