Recall Z-0176-2019 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
| Date | Sep 13, 2018 |
| Status | Terminated |
| Reason | The service manual was not updated at the time of the release of software version 1.30. |
| Root cause | Error in labeling |
| Action | Urgent Medical Device Recall notification letters dated 8/27/18 were sent to customers. |
| Quantity | 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 R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172220 | Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation, Aug 17, 2017 |