FDA Device recall Z-2009-2012
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours o…
- FDA Device
- Class II
- terminated
- Published 2012-07-25
On 2012-07-25 the FDA classified a Class II recall of Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours o… by Terumo Cardiovascular Systems, citing terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2009-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-21 |
| Published | 2012-07-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Reason
Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump or module icon on the CCM " The fai
Identifiers
| code_info | Catalog number: 801763 and serial number: 0011-0335,0337-0610, 1001-1034, 1037-1049,1100, 1103-1106, 1109-1445,and 1447-1450. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2009-2012%22
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