Z-0176-2019Class II

Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188

Name: Z-0176-2019 Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Creator: Terumo Cardiovascular Systems Corporation
Published: 2018-09-13
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2018-09-13 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188 on 2018-09-13. FDA classified it as Class II and gives the reason as "The service manual was not updated at the time of the release of software version 1.30". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0176-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-13
Posted: 2018-10-18
Terminated: 2019-11-18
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The service manual was not updated at the time of the release of software version 1.30.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Urgent Medical Device Recall notification letters dated 8/27/18 were sent to customers.
Quantity in commerce: 152
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 codes and lots: All systems. UDI 00886799000588

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0176-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0176-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-18

Product code DTQ

K172220Class IIAdvanced Perfusion System 1Terumo Cardiovascular Systems Corporation / cleared 2017-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)