FDA Device recall Z-2350-2021
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
- FDA Device
- Class II
- terminated
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class II recall of Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 by Terumo Cardiovascular Systems, citing intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2350-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-08 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | n/a |
Product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Reason
intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs
Identifiers
| code_info | S/N: 01751 UDI: 00886799000588 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2350-2021%22
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