Recall Z-0176-2019— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-0176-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-13

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2018-09-13, terminated 2019-11-18. It names one FDA 510(k) clearance: K172220. Product: Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188. Reason: The service manual was not updated at the time of the release of software version 1.30..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-09-13
Terminated: 2019-11-18
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K172220 — Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation·cleared 2017-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

The service manual was not updated at the time of the release of software version 1.30.

Data sourced from openFDA. This site is unofficial and independent of the FDA.