The Recall Desk

FDA (Devices) recall action 61763

Terumo Cardiovascular Systems Corporation recalled 2 products on 2012-07-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-07-25
Critical
0
Units
1,640

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2012-07-25

    Terumo Advanced Perfusion System 1 Recalled for Network Power Failures

    Terumo is recalling 992 Advanced Perfusion System 1 units worldwide due to reports of communications and power failures in the system network.

    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…
    Category
    Distribution
    44 states
  • HighFDA (Devices)··2012-07-25

    Terumo Advanced Perfusion System 1 Recalled for Network Communication Failures

    Terumo is recalling 648 Advanced Perfusion System 1 units due to reports of communications or power failures in the system network.

    Product
    Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. 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…
    Category
    Distribution
    44 states