FDA Device recall Z-1974-2013
Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is ind…
- FDA Device
- Class II
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class II recall of Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is ind… by Terumo Cardiovascular Systems, citing terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor moveme….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1974-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-26 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.
Reason
Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires service rather than a message displayed due to pump movement while not activated.
Identifiers
| code_info | Catalog Number or Part Number: 801764 Description: 220/240V AC, Advanced Perfusion System 1 |
|---|
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-1974-2013%22
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