Drug recall
System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the…
FDA recall event 61480 · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Event ID | 61480 |
|---|---|
| Recall numbers | Z-1965-2012, Z-1966-2012 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Product type | Devices |
| Products | System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery… |
| Initiation date | Jun 22, 2012 |
| Report date | Jul 18, 2012 |
| Termination date | Nov 8, 2013 |
| City | Ann Arbor |
| State | MI |
| Country | United States |
| FEI number | 1828100 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: