Terumo Cardiovascular Systems Corporation Recall 88350
Description: Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Terumo Cardiovascular Systems Corporation Recall 88350 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2350-2021 |
| Event ID | 88350 |
| Event Description | Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 |
| Product Type | Devices |
| Distribution | International distribution in the country of Panama. |
| Quantity | 1 unit OUS |
| Recall 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 |
| Device Classification | 20210901 |
| Device Code Info | S/N: 01751 UDI: 00886799000588 |
| Center Classification Date | 20210826 |
| Recall Initiation Date | 20210608 |
| Recalling Firm | Terumo Cardiovascular Systems Corporation |
| Initial Notification | |
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