[Recalled] Central Control Module for 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,
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Central Control Module for 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 by a qualified medical |
|---|---|
| Brand / manufacturer | Terumo Cardiovascular Systems Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1958-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 22 June 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display, loss of control functions; inability to distinguish various status, alert, alarm conditions, the inability to operate the touch screen, or the CCM
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Terumo Cardiovascular Systems Corporation
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.