FDA Device recall Z-2055-2012
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…
- FDA Device
- Class II
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class II recall of 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… by Terumo Cardiovascular Systems, citing terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion S….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2055-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-22 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
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 (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System 1 centrifugal system triggers error messages and alarms; therefore it is easily recognizable by the user. The potential hazards are dependent on the application
Identifiers
| code_info | catalog number: 801763 and serial numbers: 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-2055-2012%22
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