FDA Device recall Z-0176-2019
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
- FDA Device
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188 by Terumo Cardiovascular Systems, citing the service manual was not updated at the time of the release of software version 1.30.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0176-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-13 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
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.
Identifiers
| code_info | All systems. UDI 00886799000588 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0176-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.